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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium PMNAPROXEN SODIUMStrategic Sourcing Services LLC03a331d8-c957-4949-894f-51d9bd15e0d02025-08-20WarningsExact identifier
application applno (ANDA): 209726
application number: ANDA209726
ndc (product): 70677-0064
Naproxen Sodium and Diphenhydramine HClNAPROXEN SODIUM AND DIPHENHYDRAMINEAmneal Pharmaceuticals NY LLCcaca14cf-95f2-4c60-8bba-2154b8f353a32023-12-30WarningsExact identifier
application applno (ANDA): 209726
application number: ANDA209726
ndc (product): 69238-1422

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

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