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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2018-10-23

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium PMNAPROXEN SODIUMStrategic Sourcing Services LLC7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba2025-08-20WarningsExact identifier
Naproxen Sodium PMNAPROXEN SODIUMStrategic Sourcing Services LLC03a331d8-c957-4949-894f-51d9bd15e0d02025-08-20WarningsExact identifier
Naproxen Sodium and Diphenhydramine HClNAPROXEN SODIUM AND DIPHENHYDRAMINEAmneal Pharmaceuticals NY LLCcaca14cf-95f2-4c60-8bba-2154b8f353a32023-12-30WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed

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