pioglitazone Oral Tablet

Brand(s)
Actos
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Takeda Pharmaceuticals America, Inc. (2013-11-21)
Oldest Current Product
1999-07-15
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\PIOGLITAZONE
FDAOB
ORAL\TABLET\PIOGLITAZONE HYDROCHLORIDE
SPL Active
ORAL\TABLET\PIOGLITAZONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\PIOGLITAZONE

product(s) by strength(s)

pioglitazone 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640151ActosNDATakeda Pharmaceuticals America, Inc.1999-07-15PIOGLITAZONE HYDROCHLORIDEORALTABLETNDA021073d2ddc491-88a9-4063-9150-443b4fa4330c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932048NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLETNDA021073a3fcf590-64a7-4d6e-8b5a-ee637675f716
2000937271ANDATeva Pharmaceuticals Usa Inc2015-01-01PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA077210c5c81c67-90cf-4e64-acb5-58b0358fa742
3003780048ANDAMylan Pharmaceuticals Inc.2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA07680151033f88-4938-4666-b2a9-147044ed00e3
4005913205ANDAWatson Laboratories, Inc.2012-10-26PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA076798ccf82737-754b-472e-a9bb-961fd1a3c307
5007815420ANDASandoz Inc2013-03-01PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA0786705e36173a-2b5f-4ed7-bf81-6e79d78df0c4
6136680140ANDATorrent Pharmaceuticals Limited2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA0912983d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
7167290020ANDAAccord Healthcare Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA2000448f2d7000-37ca-4e09-98ec-07d1c0354cb3
8333420054ANDAMacleods Pharmaceuticals Limited2013-02-14PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA202467482cef76-0623-4b4f-a0ea-f008c97b2281
9519910708ANDABreckenridge Pharmaceutical, Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA0784726912a5c9-309b-4641-9232-72a218240c0d
10523430053ANDALucid Pharma Llc2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA20026873e92590-87c0-4087-839e-d1aff2851a06
11633040254ANDARnabaxy Pharmaceuticals Inc.2013-02-07PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA202467f4c5d4ea-3fa9-4c7b-80eb-d1f1edbbac16
12633040311NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLETNDA0210730478f0e7-87fb-4adb-ae9b-6624555ccbe4
13658620512ANDAAurobindo Pharma Limited2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA2002681f259863-21fd-4d62-b094-4eff845944df

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950147ActosNDARebel Distributors Corp1999-07-15PIOGLITAZONE HYDROCHLORIDEORALTABLET647640151NDA021073fd156adc-3174-44da-bff7-eeaef5983f18
2499990449ActosNDALake Erie Medical Dba Quality Care Products Llc2012-02-17PIOGLITAZONE HYDROCHLORIDEORALTABLET647640151NDA0210731f93fa66-c086-4811-a9ae-7b76bfafef2b
3510790513ANDAMylan Institutional Inc.2012-09-06PIOGLITAZONE HYDROCHLORIDEORALTABLET003780048ANDA0768014b2ba1fe-5355-4d15-9f07-c3e6fec7181a
4521250127ActosNDARemedyrepack Inc.2013-04-02PIOGLITAZONE HYDROCHLORIDEORALTABLET647640151NDA021073a478354b-1b84-4752-bc6a-aaef7bdc38f7
5544580866ANDAInternational Laboratories, Inc.2015-05-01PIOGLITAZONE HYDROCHLORIDEORALTABLET000937271ANDA0772102f23c56c-2b13-4332-b945-96726deffbfe
6544580885NDA AUTHORIZED GENERICInternational Laboratories, Inc.2013-12-08PIOGLITAZONE HYDROCHLORIDEORALTABLET000932048NDA021073fb49b7d6-8071-44c7-a10c-e8116d7d5b42
7548684343ActosNDAPhysicians Total Care, Inc.2007-11-20PIOGLITAZONE HYDROCHLORIDEORALTABLET647640151NDA0210732a97ef74-b338-4655-a60b-923f86720179
8551545150ActosNDACardinal Health1999-07-15PIOGLITAZONE HYDROCHLORIDEORALTABLET647640151NDA021073730f747a-850d-4a81-89e2-200007a5db5a
9581185420ANDAClinical Solutions Wholesale2013-03-01PIOGLITAZONE HYDROCHLORIDEORALTABLET007815420ANDA0786706c6f14bb-c964-42a6-93a6-192204ae1b99
10604290330ANDAGolden State Medical Supply, Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLET519910708ANDA078472db790f58-3c27-49c3-b7f6-58344a14400e
11636293330ANDABryant Ranch Prepack2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLET167290020ANDA20004466717657-3760-463a-be2c-af6be7ed4e16
12661160504NDA AUTHORIZED GENERICMedvantx, Inc.2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLET000932048NDA021073a3ae5cba-f495-4593-b8fc-5ada34790745
13663360857ANDADispensing Solutions, Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLET167290020ANDA20004471b48b31-5b50-4c11-91a8-d3a8cc8e6bf8
14680840613ANDAAmerican Health Packaging2013-06-20PIOGLITAZONE HYDROCHLORIDEORALTABLET658620512ANDA20026817c4e369-d729-4d22-bbfd-ebf44636fba7
15680840629NDA AUTHORIZED GENERICAmerican Health Packaging2013-06-25PIOGLITAZONE HYDROCHLORIDEORALTABLET633040311NDA0210730bba1c9c-6d8b-4cb2-9682-9f3ae6d792b9
16680840649ANDAAmerican Health Packaging2014-01-22PIOGLITAZONE HYDROCHLORIDEORALTABLET007815420ANDA07867099930370-0a84-40a5-89ab-d87bbb062e77
17680840878ANDAAmerican Health Packaging2015-04-15PIOGLITAZONE HYDROCHLORIDEORALTABLET005913205ANDA076798dbdd4aac-dc2f-422a-9e0e-176699e6fc92
18681513792NDA AUTHORIZED GENERICCarilion Materials Management2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLET000932048NDA021073f4ca7537-ed49-4dee-9003-48dc001a9dc1

pioglitazone 30 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640301ActosNDATakeda Pharmaceuticals America, Inc.1999-07-15PIOGLITAZONE HYDROCHLORIDEORALTABLETNDA021073d2ddc491-88a9-4063-9150-443b4fa4330c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932047NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLETNDA021073a3fcf590-64a7-4d6e-8b5a-ee637675f716
2000937272ANDATeva Pharmaceuticals Usa Inc2015-01-01PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA077210c5c81c67-90cf-4e64-acb5-58b0358fa742
3003780228ANDAMylan Pharmaceuticals Inc.2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA07680151033f88-4938-4666-b2a9-147044ed00e3
4005913206ANDAWatson Laboratories, Inc.2012-10-26PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA076798ccf82737-754b-472e-a9bb-961fd1a3c307
5007815421ANDASandoz Inc2013-03-01PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA0786705e36173a-2b5f-4ed7-bf81-6e79d78df0c4
6167290021ANDAAccord Healthcare Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA2000448f2d7000-37ca-4e09-98ec-07d1c0354cb3
7333420055ANDAMacleods Pharmaceuticals Limited2013-02-14PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA202467482cef76-0623-4b4f-a0ea-f008c97b2281
8519910709ANDABreckenridge Pharmaceutical, Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA0784726912a5c9-309b-4641-9232-72a218240c0d
9523430054ANDALucid Pharma Llc2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA20026873e92590-87c0-4087-839e-d1aff2851a06
10633040255ANDARnabaxy Pharmaceuticals Inc.2013-02-07PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA202467f4c5d4ea-3fa9-4c7b-80eb-d1f1edbbac16
11633040312NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLETNDA0210730478f0e7-87fb-4adb-ae9b-6624555ccbe4
12658620513ANDAAurobindo Pharma Limited2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA2002681f259863-21fd-4d62-b094-4eff845944df

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950148ActosNDARebel Distributors Corp1999-07-15PIOGLITAZONE HYDROCHLORIDEORALTABLET647640301NDA021073fd156adc-3174-44da-bff7-eeaef5983f18
2499990450ActosNDALake Erie Medical Dba Quality Care Products Llc2012-02-17PIOGLITAZONE HYDROCHLORIDEORALTABLET647640301NDA0210731f93fa66-c086-4811-a9ae-7b76bfafef2b
3510790514ANDAMylan Institutional Inc.2012-09-06PIOGLITAZONE HYDROCHLORIDEORALTABLET003780228ANDA0768014b2ba1fe-5355-4d15-9f07-c3e6fec7181a
4544580865ANDAInternational Laboratories, Inc.2015-05-01PIOGLITAZONE HYDROCHLORIDEORALTABLET000937272ANDA0772102f23c56c-2b13-4332-b945-96726deffbfe
5544580884NDA AUTHORIZED GENERICInternational Laboratories, Inc.2013-12-08PIOGLITAZONE HYDROCHLORIDEORALTABLET000932047NDA021073fb49b7d6-8071-44c7-a10c-e8116d7d5b42
6548684354ActosNDAPhysicians Total Care, Inc.2005-03-04PIOGLITAZONE HYDROCHLORIDEORALTABLET647640301NDA0210732a97ef74-b338-4655-a60b-923f86720179
7551545151ActosNDACardinal Health1999-07-15PIOGLITAZONE HYDROCHLORIDEORALTABLET647640301NDA021073730f747a-850d-4a81-89e2-200007a5db5a
8604290331ANDAGolden State Medical Supply, Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLET519910709ANDA078472db790f58-3c27-49c3-b7f6-58344a14400e
9680840614ANDAAmerican Health Packaging2013-06-20PIOGLITAZONE HYDROCHLORIDEORALTABLET658620513ANDA20026817c4e369-d729-4d22-bbfd-ebf44636fba7
10680840630NDA AUTHORIZED GENERICAmerican Health Packaging2013-06-25PIOGLITAZONE HYDROCHLORIDEORALTABLET633040312NDA0210730bba1c9c-6d8b-4cb2-9682-9f3ae6d792b9
11680840652ANDAAmerican Health Packaging2014-01-22PIOGLITAZONE HYDROCHLORIDEORALTABLET007815421ANDA07867099930370-0a84-40a5-89ab-d87bbb062e77
12681513798NDA AUTHORIZED GENERICCarilion Materials Management2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLET000932047NDA0210737547c308-3c83-429c-b761-0610d775317d

pioglitazone 45 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640451ActosNDATakeda Pharmaceuticals America, Inc.1999-07-15PIOGLITAZONE HYDROCHLORIDEORALTABLETNDA021073d2ddc491-88a9-4063-9150-443b4fa4330c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932046NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLETNDA021073a3fcf590-64a7-4d6e-8b5a-ee637675f716
2000937273ANDATeva Pharmaceuticals Usa Inc2015-01-01PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA077210c5c81c67-90cf-4e64-acb5-58b0358fa742
3003780318ANDAMylan Pharmaceuticals Inc.2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA07680151033f88-4938-4666-b2a9-147044ed00e3
4005913207ANDAWatson Laboratories, Inc.2012-10-26PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA076798ccf82737-754b-472e-a9bb-961fd1a3c307
5007815422ANDASandoz Inc2013-03-01PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA0786705e36173a-2b5f-4ed7-bf81-6e79d78df0c4
6167290022ANDAAccord Healthcare Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA2000448f2d7000-37ca-4e09-98ec-07d1c0354cb3
7333420056ANDAMacleods Pharmaceuticals Limited2013-02-14PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA202467482cef76-0623-4b4f-a0ea-f008c97b2281
8519910710ANDABreckenridge Pharmaceutical, Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA0784726912a5c9-309b-4641-9232-72a218240c0d
9523430055ANDALucid Pharma Llc2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA20026873e92590-87c0-4087-839e-d1aff2851a06
10633040261ANDARnabaxy Pharmaceuticals Inc.2013-02-07PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA202467f4c5d4ea-3fa9-4c7b-80eb-d1f1edbbac16
11633040313NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2012-08-17PIOGLITAZONE HYDROCHLORIDEORALTABLETNDA0210730478f0e7-87fb-4adb-ae9b-6624555ccbe4
12658620514ANDAAurobindo Pharma Limited2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLETANDA2002681f259863-21fd-4d62-b094-4eff845944df

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1499990451ActosNDALake Erie Medical Dba Quality Care Products Llc2012-02-17PIOGLITAZONE HYDROCHLORIDEORALTABLET647640451NDA0210731f93fa66-c086-4811-a9ae-7b76bfafef2b
2510790515ANDAMylan Institutional Inc.2012-09-06PIOGLITAZONE HYDROCHLORIDEORALTABLET003780318ANDA0768014b2ba1fe-5355-4d15-9f07-c3e6fec7181a
3544580864ANDAInternational Laboratories, Inc.2015-05-01PIOGLITAZONE HYDROCHLORIDEORALTABLET000937273ANDA0772102f23c56c-2b13-4332-b945-96726deffbfe
4544580883NDA AUTHORIZED GENERICInternational Laboratories, Inc.2013-12-08PIOGLITAZONE HYDROCHLORIDEORALTABLET000932046NDA021073fb49b7d6-8071-44c7-a10c-e8116d7d5b42
5548684391ActosNDAPhysicians Total Care, Inc.2009-10-22PIOGLITAZONE HYDROCHLORIDEORALTABLET647640451NDA0210732a97ef74-b338-4655-a60b-923f86720179
6551545152ActosNDACardinal Health1999-07-15PIOGLITAZONE HYDROCHLORIDEORALTABLET647640451NDA021073730f747a-850d-4a81-89e2-200007a5db5a
7604290332ANDAGolden State Medical Supply, Inc.2013-02-13PIOGLITAZONE HYDROCHLORIDEORALTABLET519910710ANDA078472db790f58-3c27-49c3-b7f6-58344a14400e
8680840615ANDAAmerican Health Packaging2013-06-20PIOGLITAZONE HYDROCHLORIDEORALTABLET658620514ANDA20026817c4e369-d729-4d22-bbfd-ebf44636fba7
9680840631NDA AUTHORIZED GENERICAmerican Health Packaging2013-06-25PIOGLITAZONE HYDROCHLORIDEORALTABLET633040313NDA0210730bba1c9c-6d8b-4cb2-9682-9f3ae6d792b9
10680840660ANDAAmerican Health Packaging2014-01-22PIOGLITAZONE HYDROCHLORIDEORALTABLET007815422ANDA07867099930370-0a84-40a5-89ab-d87bbb062e77

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076798PIOGLITAZONE HYDROCHLORIDEWATSON LABORATORIES2012-10-26ANDA076798_001, ANDA076798_002, ANDA076798_003
2ANDA076801PIOGLITAZONE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2012-08-17ANDA076801_001, ANDA076801_002, ANDA076801_003
3ANDA077210PIOGLITAZONE HYDROCHLORIDETEVA PHARMACEUTICALS USA2014-01-10ANDA077210_001, ANDA077210_002, ANDA077210_003
4ANDA078383PIOGLITAZONE HYDROCHLORIDEDR REDDYS LABORATORIES LTD2013-03-12ANDA078383_001, ANDA078383_002, ANDA078383_003
5ANDA078472PIOGLITAZONE HYDROCHLORIDEBRECKENRIDGE PHARMACEUTICAL INC2013-02-13ANDA078472_001, ANDA078472_002, ANDA078472_003
6ANDA078670PIOGLITAZONE HYDROCHLORIDESANDOZ INC2013-02-13ANDA078670_001, ANDA078670_002, ANDA078670_003
7ANDA091298PIOGLITAZONE HYDROCHLORIDETORRENT PHARMACEUTICALS LTD2013-02-13ANDA091298_001, ANDA091298_002, ANDA091298_003
8ANDA200044PIOGLITAZONE HYDROCHLORIDEACCORD HEALTHCARE INC2013-02-13ANDA200044_001, ANDA200044_002, ANDA200044_003
9ANDA200268PIOGLITAZONE HYDROCHLORIDEAUROBINDO PHARMA LTD2013-02-13ANDA200268_001, ANDA200268_002, ANDA200268_003
10ANDA202456PIOGLITAZONE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INC2013-02-13ANDA202456_001, ANDA202456_002, ANDA202456_003
11ANDA202467PIOGLITAZONE HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTD2013-02-06ANDA202467_001, ANDA202467_002, ANDA202467_003
12ANDA204133PIOGLITAZONE HYDROCHLORIDELUPIN LTD2014-04-07ANDA204133_001, ANDA204133_002, ANDA204133_003
13NDA021073ACTOSTAKEDA PHARMACEUTICALS USA INC1999-07-15p6211205, METHOD OF REDUCING AMOUNT OF RESPECTIVE ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA (INCLUDING PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
p5965584, AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES
p6303640, METHOD OF REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMIN TO A DIABETIC BY ADMIN A CHEMICAL COMPOUND HAVING FORMULA (INCL PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
p6150384, A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
p6150383, A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA (WHICH INCLUDES PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
p6172090, A METHOD FOR REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
p6271243, METHOD OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA (WHICH INCLUDES PIOGLITAZONE) IN COMBINATION WITH AN INSULIN PREPARATION
p6329404, AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES
p6166043, A METHOD FOR REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
p6166042, A METHOD OF TREATING GLYCOMETABOLISM DISORDERS BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
NDA021073_001, NDA021073_002, NDA021073_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076798_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2012-10-26PIOGLITAZONE HYDROCHLORIDE
2ANDA076798_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2012-10-26PIOGLITAZONE HYDROCHLORIDE
3ANDA076798_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2012-10-26PIOGLITAZONE HYDROCHLORIDE
4ANDA076801_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2012-08-17PIOGLITAZONE HYDROCHLORIDE
5ANDA076801_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2012-08-17PIOGLITAZONE HYDROCHLORIDE
6ANDA076801_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2012-08-17PIOGLITAZONE HYDROCHLORIDE
7ANDA077210_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2014-01-10PIOGLITAZONE HYDROCHLORIDE
8ANDA077210_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2014-01-10PIOGLITAZONE HYDROCHLORIDE
9ANDA077210_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2014-01-10PIOGLITAZONE HYDROCHLORIDE
10ANDA078383_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2013-03-12PIOGLITAZONE HYDROCHLORIDE
11ANDA078383_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2013-03-12PIOGLITAZONE HYDROCHLORIDE
12ANDA078383_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2013-03-12PIOGLITAZONE HYDROCHLORIDE
13ANDA078472_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
14ANDA078472_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
15ANDA078472_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
16ANDA078670_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
17ANDA078670_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
18ANDA078670_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
19ANDA091298_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
20ANDA091298_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
21ANDA091298_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
22ANDA200044_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
23ANDA200044_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
24ANDA200044_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
25ANDA200268_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
26ANDA200268_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
27ANDA200268_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
28ANDA202456_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
29ANDA202456_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
30ANDA202456_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2013-02-13PIOGLITAZONE HYDROCHLORIDE
31ANDA202467_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2013-02-06PIOGLITAZONE HYDROCHLORIDE
32ANDA202467_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2013-02-06PIOGLITAZONE HYDROCHLORIDE
33ANDA202467_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2013-02-06PIOGLITAZONE HYDROCHLORIDE
34ANDA204133_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB2014-04-07PIOGLITAZONE HYDROCHLORIDE
35ANDA204133_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB2014-04-07PIOGLITAZONE HYDROCHLORIDE
36ANDA204133_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalseAB2014-04-07PIOGLITAZONE HYDROCHLORIDE
37NDA021073_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB1999-07-15ACTOS
38NDA021073_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalseAB1999-07-15ACTOS
39NDA021073_003RXPIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETTrueAB1999-07-15ACTOS

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5965584 (view patent)2016-06-19NDA021073, NDA021410, NDA021842, NDA022024, NDA022426, NDA203414Metformin / rosiglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
2p6150383 (view patent)2016-06-19NDA021073, NDA021925, NDA022271, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
3p6150384 (view patent)2016-06-19NDA021073, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
4p6166042 (view patent)2016-06-19NDA021073, NDA021410, NDA021842, NDA022024, NDA022426, NDA203414Metformin / rosiglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
5p6166043 (view patent)2016-06-19NDA021073, NDA021842, NDA022024, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
6p6172090 (view patent)2016-06-19NDA021073, NDA021842, NDA022024, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
7p6211205 (view patent)2016-06-19NDA021073, NDA021925, NDA022271, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
8p6271243 (view patent)2016-06-19NDA021073, NDA022426alogliptin / pioglitazone Oral Tablet
9p6303640 (view patent)2016-08-09NDA021073, NDA021925, NDA022271, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
10p6329404 (view patent)2016-06-19NDA021073, NDA021925, NDA022271, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10478f0e7-87fb-4adb-ae9b-6624555ccbe4 (view SPL)These highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets.Pioglitazone Tablets for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.2012-10-312633040311, 633040312, 633040313
20bba1c9c-6d8b-4cb2-9682-9f3ae6d792b9 (view SPL)These highlights do not include all the information needed to use Pioglitazone Hydrochloride Tablets safely and effectively. See full prescribing information for Pioglitazone Hydrochloride Tablets.Pioglitazone Hydrochloride Tablets for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-06-251680840629, 680840630, 680840631
317c4e369-d729-4d22-bbfd-ebf44636fba7 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets, USP safely and effectively. See full prescribing information for pioglitazone tablets, USP. Pioglitazone Tablets, USP for Oral UseInitial U.S. Approval: 1999prescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-06-202680840613, 680840614, 680840615
41f259863-21fd-4d62-b094-4eff845944df (view SPL)These highlights do not include all the information needed to use pioglitazone tablets, USP safely and effectively. See full prescribing information for pioglitazone tablets, USP. PIOGLITAZONE Tablets USP, for Oral Use Initial U.S. Approval: 1999prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2013-12-104658620512, 658620513, 658620514
51f93fa66-c086-4811-a9ae-7b76bfafef2b (view SPL)These highlights do not include all the information needed to use ACTOS safely and effectively. See full prescribing information for ACTOS.ACTOS (pioglitazone hydrochloride) tablets for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-02-223584499990449, 499990450, 499990451
62a97ef74-b338-4655-a60b-923f86720179 (view SPL)These highlights do not include all the information needed to use ACTOS safely and effectively. See full prescribing information for ACTOS.ACTOS (pioglitazone hydrochloride) tablets for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-243548684343, 548684354, 548684391
72f23c56c-2b13-4332-b945-96726deffbfe (view SPL)These highlights do not include all the information needed to use pioglitazone tablets USP safely and effectively. See full prescribing information for pioglitazone tablets USP.PIOGLITAZONE tablets USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionInternational Laboratories, Inc.RELABEL, REPACK2015-04-161544580864, 544580865, 544580866
83d11a0bc-26b4-49f4-a8e7-0fad1524b3d1 (view SPL)These highlights do not include all the information needed to use pioglitazone hydrochloride safely and effectively. See full prescribing information for pioglitazone hydrochloride. Pioglitazone Tablets, USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionTorrent Pharmaceuticals Limitedmanufacture2015-11-033136680140
9482cef76-0623-4b4f-a0ea-f008c97b2281 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets USP safely and effectively. See full prescribing information for pioglitazone tablets USP.PIOGLITAZONE Tablets USP for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionMacleods Pharmaceuticals LimitedANALYSIS, LABEL, MANUFACTURE, PACK2015-04-013333420054, 333420055, 333420056
104b2ba1fe-5355-4d15-9f07-c3e6fec7181a (view SPL)These highlights do not include all the information needed to use pioglitazone tablets safely and effectively. See full prescribing information for pioglitazone tablets.PIOGLITAZONE tablets, USP for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionMylan Institutional Inc.2014-03-072510790513, 510790514, 510790515
1151033f88-4938-4666-b2a9-147044ed00e3 (view SPL)These highlights do not include all the information needed to use PIOGLITAZONE TABLETS, USP safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS, USP.PIOGLITAZONE tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-09-234003780048, 003780228, 003780318
125e36173a-2b5f-4ed7-bf81-6e79d78df0c4 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets, USP safely and effectively. See full prescribing information for pioglitazone tablets, USP.PIOGLITAZONE Tablets, USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionSandoz Inc2014-01-104007815420, 007815421, 007815422
1366717657-3760-463a-be2c-af6be7ed4e16 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets safely and effectively. See full prescribing information for pioglitazone tablets.Pioglitazone Tablets USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-04-281000636293330
146912a5c9-309b-4641-9232-72a218240c0d (view SPL)These highlights do not include all the information needed to use Pioglitazone Tablets, USP safely and effectively. See full prescribing information for Pioglitazone Tablets, USP. Pioglitazone Tablets, USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2013-02-061519910708, 519910709, 519910710
156c6f14bb-c964-42a6-93a6-192204ae1b99 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets, USP safely and effectively. See full prescribing information for pioglitazone tablets, USP.Pioglitazone Tablets, USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-10-281581185420
1671b48b31-5b50-4c11-91a8-d3a8cc8e6bf8 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets safely and effectively. See full prescribing information for pioglitazone tablets.Pioglitazone Tablets USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-07-153663360857
17730f747a-850d-4a81-89e2-200007a5db5a (view SPL)These highlights do not include all the information needed to use ACTOS safely and effectively. See full prescribing information for ACTOS.ACTOS (pioglitazone hydrochloride) tablets for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionCardinal HealthREPACK2013-04-264551545150, 551545151, 551545152
1873e92590-87c0-4087-839e-d1aff2851a06 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets, USP safely and effectively. See full prescribing information for pioglitazone tablets, USP. Pioglitazone Tablets, USP for Oral UseInitial U.S. Approval: 1999prescriptionHuman PrescriptionLucid Pharma LlcANALYSIS, MANUFACTURE2013-08-201523430053, 523430054, 523430055
197547c308-3c83-429c-b761-0610d775317d (view SPL)These highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets. Pioglitazone Tablets for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-10-312681513798
208f2d7000-37ca-4e09-98ec-07d1c0354cb3 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets safely and effectively. See full prescribing information for pioglitazone tablets. Pioglitazone Tablets USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2015-10-233167290020, 167290021, 167290022
2199930370-0a84-40a5-89ab-d87bbb062e77 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets, USP safely and effectively. See full prescribing information for pioglitazone tablets, USP.Pioglitazone Tablets, USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-231680840649, 680840652, 680840660
22a3ae5cba-f495-4593-b8fc-5ada34790745 (view SPL)These highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets.Pioglitazone Tablets for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionMedvantx, Inc.REPACK2012-10-311661160504
23a3fcf590-64a7-4d6e-8b5a-ee637675f716 (view SPL)These highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets.Pioglitazone Tablets for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2012-10-312000932046, 000932047, 000932048
24a478354b-1b84-4752-bc6a-aaef7bdc38f7 (view SPL)These highlights do not include all the information needed to use ACTOS safely and effectively. See full prescribing information for ACTOS.ACTOS (pioglitazone) tablets for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-021521250127
25c5c81c67-90cf-4e64-acb5-58b0358fa742 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets USP safely and effectively. See full prescribing information for pioglitazone tablets USP.PIOGLITAZONE tablets USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-01-011000937271, 000937272, 000937273
26ccf82737-754b-472e-a9bb-961fd1a3c307 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets safely and effectively. See full prescribing information for pioglitazone tablets. PIOGLITAZONE TABLETS USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, MANUFACTURE2014-04-0112005913205, 005913206, 005913207
27d2ddc491-88a9-4063-9150-443b4fa4330c (view SPL)These highlights do not include all the information needed to use ACTOS safely and effectively. See full prescribing information for ACTOS.ACTOS (pioglitazone) tablets for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.ANALYSIS, MANUFACTURE2013-11-2112647640151, 647640301, 647640451
28db790f58-3c27-49c3-b7f6-58344a14400e (view SPL)These highlights do not include all the information needed to use Pioglitazone Tablets, USP safely and effectively. See full prescribing information for Pioglitazone Tablets, USP. Pioglitazone Tablets, USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-01-031604290330, 604290331, 604290332
29dbdd4aac-dc2f-422a-9e0e-176699e6fc92 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets safely and effectively. See full prescribing information for pioglitazone tablets.PIOGLITAZONE TABLETS USP for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-04-101680840878
30f4c5d4ea-3fa9-4c7b-80eb-d1f1edbbac16 (view SPL)These highlights do not include all the information needed to use pioglitazone tablets USP safely and effectively. See full prescribing information for pioglitazone tablets USP.Pioglitazone Tablets USP for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.2013-06-124633040254, 633040255, 633040261
31f4ca7537-ed49-4dee-9003-48dc001a9dc1 (view SPL)These highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets. Pioglitazone Tablets for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-10-312681513792
32fb49b7d6-8071-44c7-a10c-e8116d7d5b42 (view SPL)These highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets. Pioglitazone Tablets for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionInternational Laboratories, Inc.MANUFACTURE, RELABEL, REPACK2015-01-063544580883, 544580884, 544580885
33fd156adc-3174-44da-bff7-eeaef5983f18 (view SPL)ACTOS (pioglitazone hydrochloride) TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-017216950147, 216950148

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII