FDA.reportPublic FDA data

Application 040502

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PYRIDOSTIGMINE BROMIDEPYRIDOSTIGMINE BROMIDETABLET;ORAL60MGNoNo
002PYRIDOSTIGMINE BROMIDEPYRIDOSTIGMINE BROMIDETABLET;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-2134Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-3511Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-3511Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-3511Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-3511Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEImpax GenericsANDACurrent
68084-494Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEAmerican Health PackagingANDACurrent
68084-494Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEAmerican Health PackagingANDACurrent
68084-494Pyridostigmine BromidePyridostigmine BromideAmerican Health PackagingANDACurrent
68084-494Pyridostigmine BromidePyridostigmine BromideAmerican Health PackagingANDACurrent