FDA.reportPublic FDA data

Application 040904

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAZOLAMIDEACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-787AcetazolamideAcetazolamideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-787AcetazolamideAcetazolamideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
50090-5945AcetazolamideAcetazolamideA-S Medication SolutionsANDACurrent
68084-401AcetazolamideAcetazolamideAmerican Health PackagingANDACurrent
68382-261ACETAZOLAMIDEacetazolamideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-261ACETAZOLAMIDEacetazolamideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-261ACETAZOLAMIDEacetazolamideZydus Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7681ORIG2008-12-19