FDA.reportPublic FDA data

Application 219153

Type
ANDA
Sponsor
BIONPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINEFOR SUSPENSION;ORAL40MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219153-001FAMOTIDINEFAMOTIDINE40MG/5MLFOR SUSPENSION / ORAL2025-06-23

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219153-001FAMOTIDINE40MG/5MLFOR SUSPENSION / ORAL2025-06-2384e616aacf4f…
2026-08-18 06:07:402026-07A219153-001FAMOTIDINE40MG/5MLFOR SUSPENSION / ORAL2025-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219153-001FAMOTIDINE40MG/5MLFOR SUSPENSION / ORAL2025-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219153-001FAMOTIDINE40MG/5MLFOR SUSPENSION / ORAL2025-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A219153-001FAMOTIDINE40MG/5MLFOR SUSPENSION / ORAL2025-06-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219153-001FAMOTIDINE40MG/5MLFOR SUSPENSION / ORAL2025-06-23a50c72e98297…

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 8 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINECVS Pharmacy, Inc.c4e35c7e-5c2f-4252-e053-2a95a90a82682025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINECVS Pharmacy, Inc.479a1437-a212-49d9-b272-758c0e5b72032025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBest Choicefadbd056-6510-f864-e053-6294a90aa67b2025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAurohealth LLCf2b911c7-ce24-4d3d-8fb6-c34980191f402025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAurohealth LLC6d0d8839-0680-45f6-96db-2d8edc9d46822025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWal-Mart Stores, Inc.43fb44ea-07a1-4df9-8b4a-b2249757208e2025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAmerisource Bergend8df03ab-7c5c-4c8b-a3fb-6c6081e081e72025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWALGREEN CO.2766ffe7-2f1c-48c8-8f67-0a2819dcc3be2025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWALGREEN CO.d0f74e78-7afb-49c2-e053-2a95a90a31dc2025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINENovadoz Pharmaceuticals LLC21953598-e7ec-45c2-8fca-05550a1ddf382025-04-10Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
acid reducerFAMOTIDINECVS Pharmacy373f5e28-e9e2-4af7-8a27-29b5d8f28b502025-04-07WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWestminster Pharmaceuticals, LLCc0e15f57-ab20-4030-b1d1-6aff33be7d762025-04-07Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINELEADER/ CARDINAL HEALTH 110, INC.cdd509c4-331b-4aee-935c-dfc44d5943ed2025-04-05WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWALGREEN CO.e9ded705-85c7-1380-e053-2995a90a68ec2025-04-05WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBi-Mart9974aa5e-e03f-4459-934a-ece27a8307462025-04-01WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEBryant Ranch Prepacka24e8f45-6ace-4a81-8005-c23a55dadd9a2025-03-31Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBest Choicefadb9d53-4cc6-83d6-e053-6394a90aa2e32025-03-28WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAmerisource Bergena5d88925-efca-4240-9eb5-6a9d0ac7a67e2025-03-28WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBetter Living Brands LLCf6f07e25-2b31-b0c4-e053-6294a90a8ffb2025-03-28WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEHARRIS TEETER, LLCe49e087c-ee20-3174-e053-2995a90a1d092025-03-28WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

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