FDA.reportPublic FDA data

Application 212623

Type
ANDA
Sponsor
GRANULATION TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL500MGNoNo
002METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-722Methocarbamol Tablets, USP, 500 mgMethocarbamolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-722Methocarbamol Tablets, USP, 500 mgMethocarbamolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-723Methocarbamol Tablets, USP, 750 mgMethocarbamolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-723Methocarbamol Tablets, USP, 750 mgMethocarbamolMarlex Pharmaceuticals, Inc.ANDACurrent
63561-0107Methocarbamol Tablets, USP, 500 mgMethocarbamolGranulation Technology, Inc.ANDACurrent
63561-0108Methocarbamol Tablets, USP, 750 mgMethocarbamolGranulation Technology, Inc.ANDACurrent