Chlorthalidone Oral Tablet

Brand(s)
Thalitone
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2014-03-19)
Oldest Current Product
1981-02-26
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\CHLORTHALIDONE
FDAOB
ORAL\TABLET\CHLORTHALIDONE
SPL Active
ORAL\TABLET\CHLORTHALIDONE
SPL Moiety
ORAL\TABLET\CHLORTHALIDONE

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1615700024ThalitoneNDAPfizer Laboratories Div Pfizer Inc1988-12-20CHLORTHALIDONEORALTABLETNDA019574e2eb7dad-3ea3-439c-dcbb-d1d61aa49dfc

chlorthalidone 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780222ANDAMylan Pharmaceuticals Inc.1981-02-26CHLORTHALIDONEORALTABLETANDA08683115dd224a-87ad-48dc-80b1-e8382a452c4c
2510790058ANDAMylan Institutional Inc.2013-05-03CHLORTHALIDONEORALTABLETANDA086831193c85ba-43c2-4be2-82cf-7b394a83390e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790015ANDAKaiser Foundations Hospitals2009-06-08CHLORTHALIDONEORALTABLET003780222ANDA08718049ef8384-946d-43cb-b9be-f174e789d7dc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950671ANDARebel Distributors Corp2009-11-18CHLORTHALIDONEORALTABLET003780222ANDA086831c10e3a16-d94f-442f-9303-4ded0adaecc1
2500900144ANDAA-S Medication Solutions Llc1981-02-26CHLORTHALIDONEORALTABLET003780222ANDA0868317b66b8f4-a030-4727-8907-f35934ab82d4
3545690552ANDAA-S Medication Solutions Llc2012-05-07CHLORTHALIDONEORALTABLET003780222ANDA0868318b6a6635-05cb-42ad-8919-063c8facfe11
4548682007ANDAPhysicians Total Care, Inc.2003-06-09CHLORTHALIDONEORALTABLET003780222ANDA086831950bb805-3ca7-4f54-b4fb-c9e23cb33ae2
5552890067ANDAPd-Rx Pharmaceuticals, Inc.2009-11-18CHLORTHALIDONEORALTABLET003780222ANDA086831bb7112ae-3a37-4525-8c7f-c0f4100ffc0a
6636295259ANDABryant Ranch Prepack1981-02-26CHLORTHALIDONEORALTABLET003780222ANDA086831ad0e281f-f546-4aff-bc13-b85e14e9b5d1

chlorthalidone 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780213ANDAMylan Pharmaceuticals Inc.1981-02-26CHLORTHALIDONEORALTABLETANDA08683115dd224a-87ad-48dc-80b1-e8382a452c4c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1433530922ANDAAphena Pharma Solutions - Tennessee, Llc1981-02-26CHLORTHALIDONEORALTABLET003780213ANDA086831c0f9093a-0c6a-47c6-b4f8-c3685f13be04
2500900145ANDAA-S Medication Solutions Llc1981-02-26CHLORTHALIDONEORALTABLET003780213ANDA0868317b66b8f4-a030-4727-8907-f35934ab82d4
3545690554ANDAA-S Medication Solutions Llc2012-05-07CHLORTHALIDONEORALTABLET003780213ANDA0868318b6a6635-05cb-42ad-8919-063c8facfe11

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA086831CHLORTHALIDONEMYLAN PHARMACEUTICALS INCANDA086831_001, ANDA086831_002
2ANDA087029CHLORTHALIDONETrueWATSON LABORATORIES INCANDA087029_001
3ANDA087050CHLORTHALIDONETrueWATSON LABORATORIES INCANDA087050_001
4ANDA087082CHLORTHALIDONETrueWATSON LABORATORIES INCANDA087082_001
5ANDA087100CHLORTHALIDONETrueWATSON LABORATORIES INCANDA087100_001
6ANDA087118CHLORTHALIDONETrueSANDOZ INCANDA087118_001
7ANDA087176CHLORTHALIDONETrueIVAX PHARMACEUTICALS INCANDA087176_001
8ANDA087247CHLORTHALIDONETrueSUPERPHARM CORP1983-02-09ANDA087247_001
9ANDA087292CHLORTHALIDONETrueMUTUAL PHARMACEUTICAL CO INCANDA087292_001
10ANDA087293CHLORTHALIDONETrueMUTUAL PHARMACEUTICAL CO INCANDA087293_001
11ANDA087296CHLORTHALIDONETrueWATSON LABORATORIES INCANDA087296_001
12ANDA087311CHLORTHALIDONETrueKV PHARMACEUTICAL COANDA087311_001
13ANDA087312CHLORTHALIDONETrueKV PHARMACEUTICAL COANDA087312_001
14ANDA087364CHLORTHALIDONETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA087364_001
15ANDA087380CHLORTHALIDONETrueSANDOZ INCANDA087380_001
16ANDA087381CHLORTHALIDONETrueSANDOZ INCANDA087381_001
17ANDA087384CHLORTHALIDONETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA087384_001
18ANDA087450CHLORTHALIDONETrueDAVA PHARMACEUTICALS INCANDA087450_001
19ANDA087451CHLORTHALIDONETrueDAVA PHARMACEUTICALS INCANDA087451_001
20ANDA087473CHLORTHALIDONETrueSUPERPHARM CORP1983-02-09ANDA087473_001
21ANDA087515CHLORTHALIDONETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1983-01-24ANDA087515_001
22ANDA087516CHLORTHALIDONETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1983-02-09ANDA087516_001
23ANDA087521CHLORTHALIDONETrueWATSON LABORATORIES INCANDA087521_001
24ANDA087555CHLORTHALIDONETrueIVAX PHARMACEUTICALS INCANDA087555_001
25ANDA087689CHLORTHALIDONETrueWATSON LABORATORIES INCANDA087689_001
26ANDA087698CHLORTHALIDONETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1982-10-20ANDA087698_001
27ANDA087699CHLORTHALIDONETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1982-10-20ANDA087699_001
28ANDA087706CHLORTHALIDONETrueWATSON LABORATORIES INCANDA087706_001
29ANDA087947CHLORTHALIDONETrueIVAX PHARMACEUTICALS INC1984-02-27ANDA087947_001
30ANDA088012CHLORTHALIDONETrueVANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO1982-07-14ANDA088012_001
31ANDA088051THALITONETrueMONARCH PHARMACEUTICALS INC1982-11-12ANDA088051_001
32ANDA088073CHLORTHALIDONETrueVANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO1983-03-25ANDA088073_001
33ANDA088139CHLORTHALIDONETruePUREPAC PHARMACEUTICAL CO1986-07-16ANDA088139_001
34ANDA088140CHLORTHALIDONETruePUREPAC PHARMACEUTICAL CO1983-08-11ANDA088140_001
35ANDA088164CHLORTHALIDONETrueIVAX PHARMACEUTICALS INC1984-01-09ANDA088164_001
36ANDA088651CHLORTHALIDONETrueG AND W LABORATORIES INC1985-05-30ANDA088651_001
37ANDA088902CHLORTHALIDONETrueBARR LABORATORIES INC1985-09-19ANDA088902_001
38ANDA088903CHLORTHALIDONETrueBARR LABORATORIES INC1985-09-19ANDA088903_001
39ANDA089051CHLORTHALIDONETrueUSL PHARMA INC1987-06-01ANDA089051_001
40ANDA089052CHLORTHALIDONETrueUSL PHARMA INC1987-06-01ANDA089052_001
41ANDA089285CHLORTHALIDONETrueMUTUAL PHARMACEUTICAL CO INC1986-07-21ANDA089285_001
42ANDA089286CHLORTHALIDONEMUTUAL PHARMACEUTICAL CO INC1986-07-21ANDA089286_001
43ANDA089591CHLORTHALIDONETruePIONEER PHARMACEUTICALS INC1988-07-21ANDA089591_001
44ANDA089738CHLORTHALIDONETrueMUTUAL PHARMACEUTICAL CO INC1988-09-19ANDA089738_001
45ANDA089739CHLORTHALIDONETrueMUTUAL PHARMACEUTICAL CO INC1988-09-19ANDA089739_001
46NDA012283HYGROTONTrueSANOFI AVENTIS US LLCNDA012283_003, NDA012283_004
47NDA019574THALITONETrueCITRON PHARMA LLC1988-12-20NDA019574_001, NDA019574_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA086831_001RXCHLORTHALIDONE (50MG)ORALTABLETTrueABCHLORTHALIDONE
2ANDA086831_002RXCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
3ANDA087029_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
4ANDA087050_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
5ANDA087082_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
6ANDA087100_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
7ANDA087118_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
8ANDA087176_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
9ANDA087247_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1983-02-09CHLORTHALIDONE
10ANDA087292_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
11ANDA087293_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
12ANDA087296_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
13ANDA087311_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
14ANDA087312_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
15ANDA087364_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
16ANDA087380_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
17ANDA087381_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
18ANDA087384_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
19ANDA087450_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
20ANDA087451_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
21ANDA087473_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1983-02-09CHLORTHALIDONE
22ANDA087515_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1983-01-24CHLORTHALIDONE
23ANDA087516_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1983-02-09CHLORTHALIDONE
24ANDA087521_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
25ANDA087555_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
26ANDA087689_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseCHLORTHALIDONE
27ANDA087698_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1982-10-20CHLORTHALIDONE
28ANDA087699_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1982-10-20CHLORTHALIDONE
29ANDA087706_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseCHLORTHALIDONE
30ANDA087947_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1984-02-27CHLORTHALIDONE
31ANDA088012_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1982-07-14CHLORTHALIDONE
32ANDA088051_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1982-11-12THALITONE
33ANDA088073_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1983-03-25CHLORTHALIDONE
34ANDA088139_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1986-07-16CHLORTHALIDONE
35ANDA088140_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1983-08-11CHLORTHALIDONE
36ANDA088164_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1984-01-09CHLORTHALIDONE
37ANDA088651_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1985-05-30CHLORTHALIDONE
38ANDA088902_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1985-09-19CHLORTHALIDONE
39ANDA088903_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1985-09-19CHLORTHALIDONE
40ANDA089051_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1987-06-01CHLORTHALIDONE
41ANDA089052_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1987-06-01CHLORTHALIDONE
42ANDA089285_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1986-07-21CHLORTHALIDONE
43ANDA089286_001RXCHLORTHALIDONE (50MG)ORALTABLETFalseAB1986-07-21CHLORTHALIDONE
44ANDA089591_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1988-07-21CHLORTHALIDONE
45ANDA089738_001discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1988-09-19CHLORTHALIDONE
46ANDA089739_001discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalse1988-09-19CHLORTHALIDONE
47NDA012283_003discontinuedCHLORTHALIDONE (50MG)ORALTABLETFalseHYGROTON
48NDA012283_004discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalseHYGROTON
49NDA019574_001discontinuedCHLORTHALIDONE (15MG)ORALTABLETFalse1988-12-20THALITONE
50NDA019574_002discontinuedCHLORTHALIDONE (25MG)ORALTABLETFalse1992-02-12THALITONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
115dd224a-87ad-48dc-80b1-e8382a452c4c (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-03-195003780213, 003780222
2193c85ba-43c2-4be2-82cf-7b394a83390e (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2012-10-052510790058
349ef8384-946d-43cb-b9be-f174e789d7dc (view SPL)prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2009-08-313001790015
47b66b8f4-a030-4727-8907-f35934ab82d4 (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-151500900144, 500900145
58b6a6635-05cb-42ad-8919-063c8facfe11 (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-171545690552, 545690554
6950bb805-3ca7-4f54-b4fb-c9e23cb33ae2 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2015-05-074548682007
7ad0e281f-f546-4aff-bc13-b85e14e9b5d1 (view SPL)IBU TabletsprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-231000636295259
8bb7112ae-3a37-4525-8c7f-c0f4100ffc0a (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-11-162552890067
9c0f9093a-0c6a-47c6-b4f8-c3685f13be04 (view SPL)prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-05-271433530922
10c10e3a16-d94f-442f-9303-4ded0adaecc1 (view SPL)ChlorthalidoneprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-161216950671
11e2eb7dad-3ea3-439c-dcbb-d1d61aa49dfc (view SPL)Thalitone (chlorthalidone tablets, USP) 15 mgprescriptionHuman PrescriptionPfizer Laboratories Div Pfizer Inc2011-07-224615700024

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