Chlorothiazide Injectable Solution

Brand(s)
Diuril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Oak Pharmaceuticals, Inc. (Subsidiary Of Akorn, Inc.) (2012-08-10)
Oldest Current Product
1958-10-03
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTABLE SOLUTION\CHLOROTHIAZIDE
FDAOB
INJECTION\INJECTION\CHLOROTHIAZIDE SODIUM\rdfq
ORAL\TABLET\CHLOROTHIAZIDE
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CHLOROTHIAZIDE SODIUM
INTRAVENOUS\INJECTION\CHLOROTHIAZIDE SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CHLOROTHIAZIDE
INTRAVENOUS\INJECTION\CHLOROTHIAZIDE

product(s) by strength(s)

chlorothiazide 28 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1764780711DiurilNDAOak Pharmaceuticals, Inc. (Subsidiary Of Akorn, Inc.)1958-10-03CHLOROTHIAZIDE SODIUMINTRAVENOUSINJECTIONNDA0111451d9fa4e6-6516-45cd-a316-292c6a529ecc

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005171820ANDAAmerican Regent, Inc.2015-04-01CHLOROTHIAZIDE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA202561850960a3-9fe2-4999-81eb-b0ae9ba011bc
2174780419NDA AUTHORIZED GENERICAkorn2012-08-13CHLOROTHIAZIDE SODIUMINTRAVENOUSINJECTIONNDA0111455046a4d7-7742-4f19-930a-2582cb41474e
3250210305ANDASagent Pharmaceuticals2015-10-12CHLOROTHIAZIDE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA202462377dc515-e381-4196-8bc7-b738606c57ac
4473350330ANDASun Pharma Global Fze2011-08-05CHLOROTHIAZIDE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091546187240e9-1eed-45ec-befb-18647d175112
5633230658ANDAApp Pharmaceuticals, Llc2009-10-21CHLOROTHIAZIDE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0908965b5d8a97-1428-4047-8e6c-b778429a26e4, de250776-461a-4d02-a82e-ffedca1a9cf4, de512e9b-444c-4ae4-8c6b-accd87a02021
6674570263ANDAMylan Institutional Llc2014-08-08CHLOROTHIAZIDE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA2024931e3abdf3-5810-42f3-ba5d-be5934c41f40

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA084026CHLOROTHIAZIDETrueWATSON LABORATORIES INC1982-09-01ANDA084026_001Chlorothiazide Oral Tablet
2ANDA084217CHLOROTHIAZIDEMYLAN PHARMACEUTICALS INCANDA084217_001Chlorothiazide Oral Tablet
3ANDA084388CHLOROTHIAZIDEMYLAN PHARMACEUTICALS INCANDA084388_001Chlorothiazide Oral Tablet
4ANDA085165CHLOROTHIAZIDETrueWATSON LABORATORIES INCANDA085165_001Chlorothiazide Oral Tablet
5ANDA085173CHLOROTHIAZIDETrueWATSON LABORATORIES INCANDA085173_001Chlorothiazide Oral Tablet
6ANDA085485CHLOROTHIAZIDETrueSANDOZ INCANDA085485_001Chlorothiazide Oral Tablet
7ANDA085569CHLOROTHIAZIDETrueABC HOLDING CORPANDA085569_001Chlorothiazide Oral Tablet
8ANDA086028CHLOROTHIAZIDETrueHIKMA INTERNATIONAL PHARMACEUTICALS LLC1982-07-14ANDA086028_001Chlorothiazide Oral Tablet
9ANDA086795CHLOROTHIAZIDETrueWATSON LABORATORIES INC1983-08-15ANDA086795_001Chlorothiazide Oral Tablet
10ANDA086796CHLOROTHIAZIDETrueWATSON LABORATORIES INC1983-08-15ANDA086796_001Chlorothiazide Oral Tablet
11ANDA086938CHLOROTHIAZIDETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA086938_001Chlorothiazide Oral Tablet
12ANDA086940CHLOROTHIAZIDETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA086940_001Chlorothiazide Oral Tablet
13ANDA087736CHLOROTHIAZIDETrueHIKMA INTERNATIONAL PHARMACEUTICALS LLC1982-07-14ANDA087736_001Chlorothiazide Oral Tablet
14ANDA090896CHLOROTHIAZIDE SODIUMFRESENIUS KABI USA LLC2009-10-16ANDA090896_001
15ANDA091546CHLOROTHIAZIDE SODIUMSUN PHARMA GLOBAL FZE2011-07-26ANDA091546_001
16ANDA202462CHLOROTHIAZIDE SODIUMSAGENT PHARMACEUTICALS INC2015-05-29ANDA202462_001
17ANDA202493CHLOROTHIAZIDE SODIUMMYLAN INSTITUTIONAL LLC2014-06-18ANDA202493_001
18ANDA202561CHLOROTHIAZIDE SODIUMLUITPOLD PHARMACEUTICALS INC2013-04-22ANDA202561_001
19NDA011145DIURILOAK PHARMACEUTICALS INC SUB AKORN INCNDA011145_002, NDA011145_004, NDA011145_005Chlorothiazide Oral Tablet

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
14ANDA090896_001RXCHLOROTHIAZIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2009-10-16CHLOROTHIAZIDE SODIUM
15ANDA091546_001RXCHLOROTHIAZIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2011-07-26CHLOROTHIAZIDE SODIUM
16ANDA202462_001RXCHLOROTHIAZIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2015-05-29CHLOROTHIAZIDE SODIUM
17ANDA202493_001RXCHLOROTHIAZIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2014-06-18CHLOROTHIAZIDE SODIUM
18ANDA202561_001RXCHLOROTHIAZIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2013-04-22CHLOROTHIAZIDE SODIUM
19NDA011145_002discontinuedCHLOROTHIAZIDE (500MG)ORALTABLETFalseDIURIL
20NDA011145_004discontinuedCHLOROTHIAZIDE (250MG)ORALTABLETFalseDIURIL
21NDA011145_005RXCHLOROTHIAZIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAPDIURIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1187240e9-1eed-45ec-befb-18647d175112 (view SPL)Chlorothiazide Sodium for Injection, USPFOR THE PREPARATION OF INTRAVENOUS SOLUTIONSprescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2014-11-042473350330
21d9fa4e6-6516-45cd-a316-292c6a529ecc (view SPL)IntravenousSodium Diuril (chlorothiazide sodium)prescriptionHuman PrescriptionOak Pharmaceuticals, Inc. (Subsidiary Of Akorn, Inc.)2012-08-104764780711
31e3abdf3-5810-42f3-ba5d-be5934c41f40 (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2012-07-313674570263
4377dc515-e381-4196-8bc7-b738606c57ac (view SPL)Chlorothiazide Sodium for Injection, USP(For Intravenous Use)prescriptionHuman PrescriptionSagent Pharmaceuticals2015-10-076250210305
55046a4d7-7742-4f19-930a-2582cb41474e (view SPL)Chlorothiazide Sodium for InjectionprescriptionHuman PrescriptionAkorn2012-08-101174780419
65b5d8a97-1428-4047-8e6c-b778429a26e4 (view SPL)Chlorothiazide Sodium for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-05-071633230658
7850960a3-9fe2-4999-81eb-b0ae9ba011bc (view SPL)CHLOROTHIAZIDE SODIUM FOR INJECTION, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE, PACK2015-03-282005171820
8de250776-461a-4d02-a82e-ffedca1a9cf4 (view SPL)Chlorothiazide Sodium for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-05-071633230658
9de512e9b-444c-4ae4-8c6b-accd87a02021 (view SPL)Chlorothiazide Sodium for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2009-10-221633230658

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