Estradiol Oral Tablet

Brand(s)
Estrace
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Barr Laboratories Inc. (2013-10-03)
Oldest Current Product
1996-03-14
License(s)
ANDA
RxNORM
ORAL TABLET\ESTRADIOL
FDAOB
ORAL\TABLET\ESTRADIOL
SPL Active
ORAL\TABLET\ESTRADIOL
SPL Moiety
ORAL\TABLET\ESTRADIOL

product(s) by strength(s)

estradiol 0.5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781452ANDAMylan Pharmaceuticals Inc.1999-06-17ESTRADIOLORALTABLETANDA040326144db6ad-c4cf-45ea-b27c-a76a319dba38
2004300720EstraceANDAWarner Chilcott (Us), Llc2011-12-26ESTRADIOLORALTABLETANDA040197a3803ba3-4eee-4e2e-ac8c-821a4e6720cc
3005550899ANDABarr Laboratories Inc.1997-10-28ESTRADIOLORALTABLETANDA040197c4936878-1643-4e7f-9b0d-e4957935aef2
4005910528ANDAWatson Laboratories, Inc.1996-03-14ESTRADIOLORALTABLETANDA04011450603fd9-08fe-4bb7-80d2-1dd1e4aa4fcd

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550013ANDAHeritage Pharmaceuticals Inc.2010-11-05ESTRADIOLORALTABLETANDA040275cf9bc807-b871-4c09-924e-6252540bf5d5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790073ANDAKaiser Foundations Hospitals2010-10-07ESTRADIOLORALTABLET003781452ANDA0403266c77e113-37e3-4c86-834a-6355bb1020e9
2001791999ANDAKaiser Foundations Hospitals2015-10-14ESTRADIOLORALTABLET005550899ANDA04019774c85bb3-f682-45be-998f-06dfb2d4c5bd
3165900052ANDAStat Rx Usa Llc1997-10-22ESTRADIOLORALTABLET005550899ANDA04019764ae46f5-889c-4c13-ab07-92bebe8d5ef2
4502680290ANDAAvpak2014-02-12ESTRADIOLORALTABLET005910528ANDA04011410b9f708-0a6d-b216-8db8-106a98a52b99
5548684370ANDAPhysicians Total Care, Inc.2003-06-09ESTRADIOLORALTABLET005550899ANDA04019737f3094c-f02d-4a9c-8e30-2c4752bc62ed
6552890603ANDAPd-Rx Pharmaceuticals, Inc.2009-12-17ESTRADIOLORALTABLET003781452ANDA040326690730ea-bd69-4b57-ab9e-2e76309c8d50
7604290327ANDAGolden State Medical Supply, Inc.2014-11-26ESTRADIOLORALTABLET005910528ANDA040114118072f2-f102-4985-89f4-a5e51d0c3cff
8636292766ANDABryant Ranch Prepack1996-03-14ESTRADIOLORALTABLET005910528ANDA04011447f3f8a4-c24c-4380-af6c-ad09b055f9ff
9636295208ANDABryant Ranch Prepack1996-03-14ESTRADIOLORALTABLET005910528ANDA04011491b78bf6-7d83-4e7d-a287-bc8717ae66c4

estradiol 1 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781454ANDAMylan Pharmaceuticals Inc.1999-06-17ESTRADIOLORALTABLETANDA040326144db6ad-c4cf-45ea-b27c-a76a319dba38
2004300721EstraceANDAWarner Chilcott (Us), Llc2011-12-26ESTRADIOLORALTABLETANDA040197a3803ba3-4eee-4e2e-ac8c-821a4e6720cc
3005550886ANDABarr Laboratories Inc.1997-10-28ESTRADIOLORALTABLETANDA040197c4936878-1643-4e7f-9b0d-e4957935aef2
4005910487ANDAWatson Laboratories, Inc.1996-03-14ESTRADIOLORALTABLETANDA04011450603fd9-08fe-4bb7-80d2-1dd1e4aa4fcd

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550014ANDAHeritage Pharmaceuticals Inc.2010-11-05ESTRADIOLORALTABLETANDA040275cf9bc807-b871-4c09-924e-6252540bf5d5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790074ANDAKaiser Foundations Hospitals2010-10-20ESTRADIOLORALTABLET003781454ANDA0403266c77e113-37e3-4c86-834a-6355bb1020e9
2001790123ANDAKaiser Foundations Hospitals2012-09-12ESTRADIOLORALTABLET005550886ANDA0401978ce4e37f-b55b-40cd-a194-ded0056ca594
3105440069ANDABlenheim Pharmacal, Inc.2012-02-14ESTRADIOLORALTABLET005910487ANDA04011411312c94-4b74-51c1-e054-00144ff88e88
4165900278ANDAStat Rx Usa Llc1996-03-14ESTRADIOLORALTABLET005910487ANDA0401140e8341f1-8089-46ff-b142-1fb04209029d
5216950613ANDARebel Distributors Corp1996-03-14ESTRADIOLORALTABLET005910487ANDA040114c674e1bc-5c8e-4c59-8de5-c7fa5306706d
6332610667ANDAAidarex Pharmaceuticals Llc1997-10-28ESTRADIOLORALTABLET005550886ANDA0401977712c639-36c5-4c0f-aa74-fd4161540761
7430630446ANDAPd-Rx Pharmaceuticals, Inc.1996-03-14ESTRADIOLORALTABLET005910487ANDA0401141d42bc5f-c6c3-4715-a283-d2c50baa341f
8499990083ANDALake Erie Medical Dba Quality Care Products Llc2012-03-12ESTRADIOLORALTABLET005910487ANDA040114b6c4b64a-2f0c-47ce-b423-b74d705b2de8
9502680291ANDAAvpak2014-02-12ESTRADIOLORALTABLET005910487ANDA04011410b9f708-0a6d-b216-8db8-106a98a52b99
10548684030ANDAPhysicians Total Care, Inc.2000-09-18ESTRADIOLORALTABLET005550886ANDA04019737f3094c-f02d-4a9c-8e30-2c4752bc62ed
11551546242ANDACardinal Health2009-12-17ESTRADIOLORALTABLET003781454ANDA040326ee98f923-8961-4f9f-8fa1-dcd934df89ac
12552890761ANDAPd-Rx Pharmaceuticals, Inc.2009-12-17ESTRADIOLORALTABLET003781454ANDA04032605393315-da87-4679-9ab1-7b3a289e5638
13604290328ANDAGolden State Medical Supply, Inc.2014-11-26ESTRADIOLORALTABLET005910487ANDA040114118072f2-f102-4985-89f4-a5e51d0c3cff
14619190278ANDADirect Rx2015-01-01ESTRADIOLORALTABLET005550886ANDA040197b785a171-9d2d-425b-b812-0dddfbb4b71f
15631870482ANDAProficient Rx Lp1996-03-14ESTRADIOLORALTABLET005910487ANDA040114ebd0b72e-ff16-4692-918f-eb5d1432729f
16636293755ANDABryant Ranch Prepack1996-03-14ESTRADIOLORALTABLET005910487ANDA04011422eeffba-29ad-4f1f-9a0e-ed8946f7d6be
17642050048ANDAReadymeds1996-03-14ESTRADIOLORALTABLET005910487ANDA0401143a995f9d-8b3e-4475-b818-34c4bbf4eec6
18687889416ANDAPreferred Pharmaceuticals, Inc.2014-12-04ESTRADIOLORALTABLET005910487ANDA0401147bc58020-727f-483e-95de-15cbe327c673
19687889901ANDAPreferred Pharmaceuticals, Inc.2012-02-13ESTRADIOLORALTABLET005550886ANDA040197e6c0ee96-5d2a-4725-a460-5ca62f2b6c36

estradiol 2 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781458ANDAMylan Pharmaceuticals Inc.1999-06-17ESTRADIOLORALTABLETANDA040326144db6ad-c4cf-45ea-b27c-a76a319dba38
2004300722EstraceANDAWarner Chilcott (Us), Llc2011-12-26ESTRADIOLORALTABLETANDA040197a3803ba3-4eee-4e2e-ac8c-821a4e6720cc
3005550887ANDABarr Laboratories Inc.1997-10-28ESTRADIOLORALTABLETANDA040197c4936878-1643-4e7f-9b0d-e4957935aef2
4005910488ANDAWatson Laboratories, Inc.1996-03-14ESTRADIOLORALTABLETANDA04011450603fd9-08fe-4bb7-80d2-1dd1e4aa4fcd

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550015ANDAHeritage Pharmaceuticals Inc.2010-11-05ESTRADIOLORALTABLETANDA040275cf9bc807-b871-4c09-924e-6252540bf5d5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440070ANDABlenheim Pharmacal, Inc.2012-03-05ESTRADIOLORALTABLET005910488ANDA04011411312c94-4b74-51c1-e054-00144ff88e88
2216950623ANDARebel Distributors Corp1996-03-14ESTRADIOLORALTABLET005910488ANDA040114c674e1bc-5c8e-4c59-8de5-c7fa5306706d
3332610714ANDAAidarex Pharmaceuticals Llc1997-10-28ESTRADIOLORALTABLET005550887ANDA0401977712c639-36c5-4c0f-aa74-fd4161540761
4430630201ANDAPd-Rx Pharmaceuticals, Inc.1996-03-14ESTRADIOLORALTABLET005910488ANDA040114a273ddbd-cfb2-4be4-8b29-8eb7d3f93031
5502680292ANDAAvpak2014-02-12ESTRADIOLORALTABLET005910488ANDA04011410b9f708-0a6d-b216-8db8-106a98a52b99
6548684031ANDAPhysicians Total Care, Inc.2003-05-07ESTRADIOLORALTABLET005550887ANDA04019737f3094c-f02d-4a9c-8e30-2c4752bc62ed
7604290329ANDAGolden State Medical Supply, Inc.2014-11-26ESTRADIOLORALTABLET005910488ANDA040114118072f2-f102-4985-89f4-a5e51d0c3cff
8636294788ANDABryant Ranch Prepack1996-03-14ESTRADIOLORALTABLET005910488ANDA040114bfc1beb9-1ade-446e-97dd-55b41c2fa851
9642050488ANDAReadymeds1996-03-14ESTRADIOLORALTABLET005910488ANDA0401143a995f9d-8b3e-4475-b818-34c4bbf4eec6

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040114ESTRADIOLWATSON LABORATORIES INC1996-03-14ANDA040114_001, ANDA040114_002, ANDA040114_003
2ANDA040138ESTRADIOLTrueLANNETT HOLDINGS INC1998-01-30ANDA040138_001, ANDA040138_002, ANDA040138_003
3ANDA040197ESTRADIOLBARR LABORATORIES INC1997-10-22ANDA040197_001, ANDA040197_002, ANDA040197_003
4ANDA040212GYNODIOLTrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1997-12-29ANDA040212_001, ANDA040212_002, ANDA040212_003, ANDA040212_004
5ANDA040275ESTRADIOLTrueEPIC PHARMA INC1998-12-29ANDA040275_001, ANDA040275_002, ANDA040275_003
6ANDA040297ESTRADIOLUSL PHARMA INC2002-04-17ANDA040297_001, ANDA040297_002, ANDA040297_003
7ANDA040312INNOFEMTrueNOVO NORDISK INC1999-11-19ANDA040312_001, ANDA040312_002, ANDA040312_003
8ANDA040326ESTRADIOLMYLAN PHARMACEUTICALS INC1999-04-21ANDA040326_001, ANDA040326_002, ANDA040326_003
9ANDA081295ESTRACETrueBRISTOL MYERS SQUIBB CO1993-06-30ANDA081295_001
10ANDA084499ESTRACETrueBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTEANDA084499_001
11ANDA084500ESTRACETrueBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTEANDA084500_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040114_001RXESTRADIOL (1MG)ORALTABLETFalseAB1996-03-14ESTRADIOL
2ANDA040114_002RXESTRADIOL (2MG)ORALTABLETFalseAB1996-03-14ESTRADIOL
3ANDA040114_003RXESTRADIOL (0.5MG)ORALTABLETFalseAB1996-03-14ESTRADIOL
4ANDA040138_001discontinuedESTRADIOL (0.5MG)ORALTABLETFalse1998-01-30ESTRADIOL
5ANDA040138_002discontinuedESTRADIOL (1MG)ORALTABLETFalse1998-01-30ESTRADIOL
6ANDA040138_003discontinuedESTRADIOL (2MG)ORALTABLETFalse1998-01-30ESTRADIOL
7ANDA040197_001RXESTRADIOL (0.5MG)ORALTABLETFalseAB1997-10-22ESTRADIOL
8ANDA040197_002RXESTRADIOL (1MG)ORALTABLETFalseAB1997-10-22ESTRADIOL
9ANDA040197_003RXESTRADIOL (2MG)ORALTABLETTrueAB1997-10-22ESTRADIOL
10ANDA040212_001discontinuedESTRADIOL (0.5MG)ORALTABLETFalse1997-12-29GYNODIOL
11ANDA040212_002discontinuedESTRADIOL (1MG)ORALTABLETFalse1997-12-29GYNODIOL
12ANDA040212_003discontinuedESTRADIOL (1.5MG)ORALTABLETFalse1997-12-29GYNODIOL
13ANDA040212_004discontinuedESTRADIOL (2MG)ORALTABLETFalse1997-12-29GYNODIOL
14ANDA040275_001discontinuedESTRADIOL (0.5MG)ORALTABLETFalse1998-12-29ESTRADIOL
15ANDA040275_002discontinuedESTRADIOL (1MG)ORALTABLETFalse1998-12-29ESTRADIOL
16ANDA040275_003discontinuedESTRADIOL (2MG)ORALTABLETFalse1998-12-29ESTRADIOL
17ANDA040297_001RXESTRADIOL (0.5MG)ORALTABLETFalseAB2002-04-17ESTRADIOL
18ANDA040297_002RXESTRADIOL (1MG)ORALTABLETFalseAB2002-04-17ESTRADIOL
19ANDA040297_003RXESTRADIOL (2MG)ORALTABLETFalseAB2002-04-17ESTRADIOL
20ANDA040312_001discontinuedESTRADIOL (0.5MG)ORALTABLETFalse1999-11-19INNOFEM
21ANDA040312_002discontinuedESTRADIOL (1MG)ORALTABLETFalse1999-11-19INNOFEM
22ANDA040312_003discontinuedESTRADIOL (2MG)ORALTABLETFalse1999-11-19INNOFEM
23ANDA040326_001RXESTRADIOL (0.5MG)ORALTABLETFalseAB1999-04-21ESTRADIOL
24ANDA040326_002RXESTRADIOL (1MG)ORALTABLETFalseAB1999-04-21ESTRADIOL
25ANDA040326_003RXESTRADIOL (2MG)ORALTABLETFalseAB1999-04-21ESTRADIOL
26ANDA081295_001discontinuedESTRADIOL (0.5MG)ORALTABLETFalse1993-06-30ESTRACE
27ANDA084499_001discontinuedESTRADIOL (1MG)ORALTABLETFalseESTRACE
28ANDA084500_001discontinuedESTRADIOL (2MG)ORALTABLETFalseESTRACE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
105393315-da87-4679-9ab1-7b3a289e5638 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-12-092552890761
20e8341f1-8089-46ff-b142-1fb04209029d (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-09-041165900278
310b9f708-0a6d-b216-8db8-106a98a52b99 (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionAvpak2014-09-112502680290, 502680291, 502680292
411312c94-4b74-51c1-e054-00144ff88e88 (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-131105440069, 105440070
5118072f2-f102-4985-89f4-a5e51d0c3cff (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-06-081604290327, 604290328, 604290329
6144db6ad-c4cf-45ea-b27c-a76a319dba38 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2009-12-095003781452, 003781454, 003781458
71d42bc5f-c6c3-4715-a283-d2c50baa341f (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-07-164430630446
822eeffba-29ad-4f1f-9a0e-ed8946f7d6be (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-291002636293755
937f3094c-f02d-4a9c-8e30-2c4752bc62ed (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-092548684030, 548684031, 548684370
103a995f9d-8b3e-4475-b818-34c4bbf4eec6 (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionReadymedsrepack2014-05-063642050048, 642050488
1147f3f8a4-c24c-4380-af6c-ad09b055f9ff (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636292766
1250603fd9-08fe-4bb7-80d2-1dd1e4aa4fcd (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-07-162005910487, 005910488, 005910528
1364ae46f5-889c-4c13-ab07-92bebe8d5ef2 (view SPL)Estradiol (Estradiol) tabletprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-272165900052
14690730ea-bd69-4b57-ab9e-2e76309c8d50 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-12-092552890603
156c77e113-37e3-4c86-834a-6355bb1020e9 (view SPL)prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-10-291001790073, 001790074
1674c85bb3-f682-45be-998f-06dfb2d4c5bd (view SPL)ESTRADIOL TABLETS, USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2015-10-231001791999
177712c639-36c5-4c0f-aa74-fd4161540761 (view SPL)ESTRADIOL TABLETS, USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-311332610667, 332610714
187bc58020-727f-483e-95de-15cbe327c673 (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-12-041687889416
198ce4e37f-b55b-40cd-a194-ded0056ca594 (view SPL)ESTRADIOL TABLETS, USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2012-09-191001790123
2091b78bf6-7d83-4e7d-a287-bc8717ae66c4 (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-101000636295208
21a273ddbd-cfb2-4be4-8b29-8eb7d3f93031 (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-11-163430630201
22a3803ba3-4eee-4e2e-ac8c-821a4e6720cc (view SPL)ESTRACE TABLETS(estradiol tablets, USP)prescriptionHuman PrescriptionWarner Chilcott (Us), Llc2013-09-253004300720, 004300721, 004300722
23b6c4b64a-2f0c-47ce-b423-b74d705b2de8 (view SPL)ESTRADIOL TABLETS, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-153657499990083
24b785a171-9d2d-425b-b812-0dddfbb4b71f (view SPL)ESTRADIOLprescriptionHuman PrescriptionDirect Rxrepack2015-10-281619190278
25bfc1beb9-1ade-446e-97dd-55b41c2fa851 (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-231002636294788
26c4936878-1643-4e7f-9b0d-e4957935aef2 (view SPL)ESTRADIOL TABLETS, USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-10-034005550886, 005550887, 005550899
27c674e1bc-5c8e-4c59-8de5-c7fa5306706d (view SPL)ESTRADIOL TABLETS, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-261216950613, 216950623
28cf9bc807-b871-4c09-924e-6252540bf5d5 (view SPL)ESTRADIOL TABLETS, USP Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2009-08-311231550013, 231550014, 231550015
29e6c0ee96-5d2a-4725-a460-5ca62f2b6c36 (view SPL)ESTRADIOL TABLETS, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-11-174687889901
30ebd0b72e-ff16-4692-918f-eb5d1432729f (view SPL)Estradiol Tablets USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870482
31ee98f923-8961-4f9f-8fa1-dcd934df89ac (view SPL)ESTRADIOL TABLETS, USP0.5 mg, 1 mg and 2 mgprescriptionHuman PrescriptionCardinal HealthREPACK2012-11-163551546242

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