Chlorothiazide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2006-03-16)
Oldest Current Product
1975-06-26
License(s)
ANDA
RxNORM
ORAL TABLET\CHLOROTHIAZIDE
FDAOB
INJECTION\INJECTION\CHLOROTHIAZIDE SODIUM\rdfq
ORAL\TABLET\CHLOROTHIAZIDE
SPL Active
ORAL\TABLET\CHLOROTHIAZIDE
SPL Moiety
ORAL\TABLET\CHLOROTHIAZIDE

product(s) by strength(s)

chlorothiazide 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780150ANDAMylan Pharmaceuticals Inc.1975-06-26CHLOROTHIAZIDEORALTABLETANDA084217d652ef6f-2112-43ea-ba01-c3bf4f8d8030

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001431209ANDAWest-Ward Pharmaceutical Corp2005-08-30CHLOROTHIAZIDEORALTABLETANDA08602832689670-ff81-40a1-8f2e-7a2de69cb603
2604290116ANDAGolden State Medical Supply, Inc.2005-08-30CHLOROTHIAZIDEORALTABLET001431209ANDA086028bcc8c397-a0b7-4211-8f89-fe7439a28d51

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1691890151ANDAAvera Mckennan Hospital2015-03-01CHLOROTHIAZIDEORALTABLET003780150ANDA0842175c8b25f3-7ff8-4740-8e98-2b9e32655759

chlorothiazide 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780162ANDAMylan Pharmaceuticals Inc.1975-07-17CHLOROTHIAZIDEORALTABLETANDA084217d652ef6f-2112-43ea-ba01-c3bf4f8d8030

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001431210ANDAWest-Ward Pharmaceutical Corp2005-08-30CHLOROTHIAZIDEORALTABLETANDA08773632689670-ff81-40a1-8f2e-7a2de69cb603
2604290117ANDAGolden State Medical Supply, Inc.2005-08-30CHLOROTHIAZIDEORALTABLET001431210ANDA087736bcc8c397-a0b7-4211-8f89-fe7439a28d51

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA084026CHLOROTHIAZIDETrueWATSON LABORATORIES INC1982-09-01ANDA084026_001Chlorothiazide Injectable Solution
2ANDA084217CHLOROTHIAZIDEMYLAN PHARMACEUTICALS INCANDA084217_001Chlorothiazide Injectable Solution
3ANDA084388CHLOROTHIAZIDEMYLAN PHARMACEUTICALS INCANDA084388_001Chlorothiazide Injectable Solution
4ANDA085165CHLOROTHIAZIDETrueWATSON LABORATORIES INCANDA085165_001Chlorothiazide Injectable Solution
5ANDA085173CHLOROTHIAZIDETrueWATSON LABORATORIES INCANDA085173_001Chlorothiazide Injectable Solution
6ANDA085485CHLOROTHIAZIDETrueSANDOZ INCANDA085485_001Chlorothiazide Injectable Solution
7ANDA085569CHLOROTHIAZIDETrueABC HOLDING CORPANDA085569_001Chlorothiazide Injectable Solution
8ANDA086028CHLOROTHIAZIDETrueHIKMA INTERNATIONAL PHARMACEUTICALS LLC1982-07-14ANDA086028_001Chlorothiazide Injectable Solution
9ANDA086795CHLOROTHIAZIDETrueWATSON LABORATORIES INC1983-08-15ANDA086795_001Chlorothiazide Injectable Solution
10ANDA086796CHLOROTHIAZIDETrueWATSON LABORATORIES INC1983-08-15ANDA086796_001Chlorothiazide Injectable Solution
11ANDA086938CHLOROTHIAZIDETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA086938_001Chlorothiazide Injectable Solution
12ANDA086940CHLOROTHIAZIDETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA086940_001Chlorothiazide Injectable Solution
13ANDA087736CHLOROTHIAZIDETrueHIKMA INTERNATIONAL PHARMACEUTICALS LLC1982-07-14ANDA087736_001Chlorothiazide Injectable Solution
14NDA011145DIURILOAK PHARMACEUTICALS INC SUB AKORN INCNDA011145_002, NDA011145_004, NDA011145_005Chlorothiazide Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA084026_001discontinuedCHLOROTHIAZIDE (500MG)ORALTABLETFalse1982-09-01CHLOROTHIAZIDE
2ANDA084217_001RXCHLOROTHIAZIDE (500MG)ORALTABLETFalseCHLOROTHIAZIDE
3ANDA084388_001RXCHLOROTHIAZIDE (250MG)ORALTABLETTrueCHLOROTHIAZIDE
4ANDA085165_001discontinuedCHLOROTHIAZIDE (250MG)ORALTABLETFalseCHLOROTHIAZIDE
5ANDA085173_001discontinuedCHLOROTHIAZIDE (250MG)ORALTABLETFalseCHLOROTHIAZIDE
6ANDA085485_001discontinuedCHLOROTHIAZIDE (250MG)ORALTABLETFalseCHLOROTHIAZIDE
7ANDA085569_001discontinuedCHLOROTHIAZIDE (250MG)ORALTABLETFalseCHLOROTHIAZIDE
8ANDA086028_001discontinuedCHLOROTHIAZIDE (250MG)ORALTABLETFalse1982-07-14CHLOROTHIAZIDE
9ANDA086795_001discontinuedCHLOROTHIAZIDE (250MG)ORALTABLETFalse1983-08-15CHLOROTHIAZIDE
10ANDA086796_001discontinuedCHLOROTHIAZIDE (500MG)ORALTABLETFalse1983-08-15CHLOROTHIAZIDE
11ANDA086938_001discontinuedCHLOROTHIAZIDE (500MG)ORALTABLETFalseCHLOROTHIAZIDE
12ANDA086940_001discontinuedCHLOROTHIAZIDE (250MG)ORALTABLETFalseCHLOROTHIAZIDE
13ANDA087736_001discontinuedCHLOROTHIAZIDE (500MG)ORALTABLETFalse1982-07-14CHLOROTHIAZIDE
14NDA011145_002discontinuedCHLOROTHIAZIDE (500MG)ORALTABLETFalseDIURIL
15NDA011145_004discontinuedCHLOROTHIAZIDE (250MG)ORALTABLETFalseDIURIL
16NDA011145_005RXCHLOROTHIAZIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAPDIURIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
132689670-ff81-40a1-8f2e-7a2de69cb603 (view SPL)CHLOROTHIAZIDE TABLETS, USP250 mg and 500 mgprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2009-07-233001431209, 001431210
25c8b25f3-7ff8-4740-8e98-2b9e32655759 (view SPL)prescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-061691890151
3bcc8c397-a0b7-4211-8f89-fe7439a28d51 (view SPL)CHLOROTHIAZIDE TABLETS, USP250 mg and 500 mgprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL2011-07-011604290116, 604290117
4d652ef6f-2112-43ea-ba01-c3bf4f8d8030 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2006-03-166003780150, 003780162

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