FDA.reportPublic FDA data

Application 203184

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PYRIDOSTIGMINE BROMIDEPYRIDOSTIGMINE BROMIDETABLET, EXTENDED RELEASE;ORAL180MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1404Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEImpax GenericsANDACurrent
0115-1404Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1404Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEAmneal Pharmaceuticals of New York LLCANDACurrent
68071-5032Pyridostigmine BromidePYRIDOSTIGMINE BROMIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-5032Pyridostigmine BromidePYRIDOSTIGMINE BROMIDENuCare Pharmaceuticals,Inc.ANDACurrent