FDA.reportPublic FDA data

Application 209726

Type
ANDA
Sponsor
AMNEAL PHARMS CO

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
0363-0844All Night Pain Relief PMNaproxen SodiumWalgreensANDACurrent
0363-0844All Night Pain Relief PMNaproxen SodiumWalgreensANDACurrent
0363-0844All Night Pain Relief PMNaproxen SodiumWalgreensANDACurrent
55315-844Naproxen Sodium PMNaproxen SodiumFreds IncANDACurrent
55315-844Naproxen Sodium PMNaproxen SodiumFreds IncANDACurrent
55910-854Naproxen Sodium PMNaproxen SodiumDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-854Naproxen Sodium PMNaproxen SodiumDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-854Naproxen Sodium PMNaproxen SodiumDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
62011-0396Naproxen Sodium PMNaproxen SodiumStrategic Sourcing Services LLCANDACurrent
62011-0396Naproxen Sodium PMNaproxen SodiumMcKesson (Health Mart)ANDACurrent
62011-0396Naproxen Sodium PMNaproxen SodiumStrategic Sourcing Services LLCANDACurrent
63868-411Naproxen PMNaproxen SodiumQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-411Naproxen PMNaproxen SodiumQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
69238-1422Naproxen Sodium and Diphenhydramine HClNaproxen Sodium and DiphenhydramineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1422Naproxen Sodium and Diphenhydramine HClNaproxen Sodium and DiphenhydramineAmneal Pharmaceuticals LLCANDACurrent
69238-1422Naproxen Sodium and Diphenhydramine HClNaproxen Sodium and DiphenhydramineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1422Naproxen Sodium and Diphenhydramine HClNaproxen Sodium and DiphenhydramineAmneal Pharmaceuticals NY LLCANDACurrent
70677-0064Naproxen Sodium PMNaproxen SodiumStrategic Sourcing Services LLCANDACurrent
70677-0064Naproxen Sodium PMNaproxen SodiumMcKesson (Sunmark)ANDACurrent
70677-0064Naproxen Sodium PMNaproxen SodiumStrategic Sourcing Services LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56477ORIG2018-11-15