FDA.reportPublic FDA data

Application 213663

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUMTABLET;ORAL25MG;220MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9766Naproxen Sodium Diphenhydramine HClNaproxen Sodium Diphenhydramine HClWALGREEN CO.ANDACurrent
62207-814Naproxen Sodium and Diphenhydramine HClNaproxen Sodium and Diphenhydramine HClGranules India LtdANDACurrent
62207-814Naproxen Sodium and Diphenhydramine HClNaproxen Sodium and Diphenhydramine HClGranules India LtdANDACurrent
62207-814Naproxen Sodium and Diphenhydramine HClNaproxen Sodium and Diphenhydramine HClGranules India LtdANDACurrent
69842-328Naproxen Sodium Diphenhydramine HClNaproxen Sodium Diphenhydramine HClCVS PHARMACY, INCANDACurrent