FDA.reportPublic FDA data

Application 203614

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL25MGNoNo
002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL35MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1709Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1709Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1709Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideImpax GenericsANDACurrent
0115-1709Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1709Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1709Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1710Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1710Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1710Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideImpax GenericsANDACurrent
0115-1710Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1710Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1710Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent