Application 203434

Type
ANDA
Sponsor
NOVAST LABS

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
50742-233AcetazolamideAcetazolamideIngenus Pharmaceuticals, LLCANDACurrent
50742-233AcetazolamideAcetazolamideIngenus Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45588ORIG2016-10-05