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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2020-09-24

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium Diphenhydramine HCLNAPROXEN SODIUM DIPHENHYDRAMINE HCLWalmartfe810c0e-ab42-5a8a-e053-6394a90affe42025-12-19WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663
Naproxen Sodium and Diphenhydramine HCLNAPROXEN SODIUM AND DIPHENHYDRAMINE HCLTARGET CORPORATIONfe82699d-fdc2-038e-e053-6294a90a606c2025-12-19WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663
Naproxen Sodium Diphenhydramine HClNAPROXEN SODIUM DIPHENHYDRAMINE HCLCVS PHARMACY, INCbdac694e-ab2a-376d-e053-2a95a90a94672025-12-19WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663
ndc (product): 69842-328
Naproxen Sodium Diphenhydramine HydrochlorideNAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDESAFEWAYed0f3275-f156-13a3-e053-2a95a90a2ce82025-12-18WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663
Naproxen Sodium and Diphenhydramine HClNAPROXEN SODIUM AND DIPHENHYDRAMINE HCLGranules India Ltd0d59780a-ef22-4b67-8b42-9795dbec8db02025-08-01WarningsExact identifier
application applno (ANDA): 213663
application number: ANDA213663
ndc (product): 62207-814

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

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