Acetazolamide Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
X-Gen Pharmaceuticals, Inc. (2015-10-08)
Oldest Current Product
2008-12-10
License(s)
ANDA
RxNORM
INJECTION\ACETAZOLAMIDE
FDAOB
INJECTION\INJECTION\ACETAZOLAMIDE SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ACETAZOLAMIDE SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ACETAZOLAMIDE

product(s) by strength(s)

acetazolamide 500 mg injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550313ANDAHeritage Pharmaceuticals Inc.2014-12-19ACETAZOLAMIDE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20269360f656ff-97b1-4a89-99af-8100483c2bac
2250210817ANDASagent Pharmaceuticals2012-06-15ACETAZOLAMIDE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA2008803a4fb00e-e4ea-48bd-803e-84322eac4075
3398220190ANDAX-Gen Pharmaceuticals, Inc.2008-12-10ACETAZOLAMIDE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA040784a9199d3c-ce52-4db5-aa36-408f4e15e344
4398220191ANDAX-Gen Pharmaceuticals, Inc.2013-12-10ACETAZOLAMIDE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA04078453331108-caed-4fd4-b920-0185eb74197c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040089ACETAZOLAMIDE SODIUMEUROHEALTH INTERNATIONAL SARL1995-02-28ANDA040089_001
2ANDA040108ACETAZOLAMIDE SODIUMTrueHOSPIRA INC1995-10-30ANDA040108_001
3ANDA040784ACETAZOLAMIDE SODIUMX GEN PHARMACEUTICALS INC2008-12-10ANDA040784_001
4ANDA200880ACETAZOLAMIDE SODIUMSAGENT AGILA LLC2012-05-09ANDA200880_001
5ANDA202693ACETAZOLAMIDE SODIUM EMCURE PHARMACEUTICALS LTD2014-12-19ANDA202693_001
6NDA009388DIAMOXTrueTEVA WOMENS HEALTH INC1990-12-05NDA009388_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040089_001RXACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP1995-02-28ACETAZOLAMIDE SODIUM
2ANDA040108_001discontinuedACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1995-10-30ACETAZOLAMIDE SODIUM
3ANDA040784_001RXACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAP2008-12-10ACETAZOLAMIDE SODIUM
4ANDA200880_001RXACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2012-05-09ACETAZOLAMIDE SODIUM
5ANDA202693_001RXACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2014-12-19ACETAZOLAMIDE SODIUM
6NDA009388_001discontinuedACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1990-12-05DIAMOX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13a4fb00e-e4ea-48bd-803e-84322eac4075 (view SPL)AcetaZOLAMIDE for Injection, USP(For Intravenous Use Only)prescriptionHuman PrescriptionSagent Pharmaceuticals2013-02-224250210817
253331108-caed-4fd4-b920-0185eb74197c (view SPL)AcetaZOLAMIDE for Injection, USPFor Intravenous UseRx OnlyprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2014-01-2419398220191
360f656ff-97b1-4a89-99af-8100483c2bac (view SPL)For Intravenous useRx OnlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-12-253231550313
4a9199d3c-ce52-4db5-aa36-408f4e15e344 (view SPL)AcetaZOLAMIDE for Injection, USPFor Intravenous UseRx OnlyprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2015-10-0822398220190

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