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 3 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEBryant Ranch Prepackdb3af7cc-efc6-4934-acff-8bb2d31fe8292026-05-19Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
good sense acid reducerFAMOTIDINEL. Perrigo Companycc77f6ff-a534-4731-b971-4912808408992026-05-18WarningsName fallback
generic name: FAMOTIDINE
Good Sense Acid ReducerFAMOTIDINEL. Perrigo Company39cb0f15-d177-46eb-a549-7acb885fbf072026-05-11WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINECardinal Health 107, LLC5d515c2a-dac9-42d8-aede-66d28a427dbc2026-05-11Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACYfebe39b1-9212-a281-e053-6394a90a1a9f2026-05-01Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINECardinal Health 107, LLCcdd5dfb7-4efb-4235-8023-5ce145c090382026-04-27Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEREMEDYREPACK INC.8dbf43e0-856f-443b-b8a4-c69e006878ea2026-04-24Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
Acid ControllerFAMOTIDINEWalgreen Company42392cb1-7958-4a2f-8622-f00f02afd9612026-04-24WarningsName fallback
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEPreferred Pharmaceuticals Inc.b445a613-eaa8-45e8-be1f-5848bfd1dd362026-04-15Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPreferred Pharmaceuticals, Inc.b1edf3c5-e42c-471b-8771-6c93094822de2026-04-15Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEPreferred Pharmaceuticals Inc.dbf94314-3a34-4f03-80b1-296559b7d6a52026-04-15Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
acid controllerFAMOTIDINECVS Pharmacy1531aa51-02e9-45ed-99aa-53b21732dd2e2026-04-06WarningsName fallback
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.3ab235f4-da59-4a92-ad6b-c76cf3ecd9852026-04-02Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEMedical Purchasing Solutions, LLC4e803491-8030-50d0-e063-6294a90a5c8d2026-04-02Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepack545d5c1f-ec1c-4135-965f-333ad888d96f2026-03-31Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.fd5d15b9-b1b5-48ef-ba41-8a43a7642e942026-03-17Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
acid reducer original strengthFAMOTIDINEHyVee Inca0f2683f-59ad-4f65-a108-696430d577ab2026-03-16WarningsName fallback
generic name: FAMOTIDINE
ACID REDUCERFAMOTIDINEPublix Super Markets Inc3455be3c-696e-402a-a5df-830544fa525a2026-03-11WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINELegacy Pharmaceutical Packaging, LLCcc88fbdc-546e-332f-e053-2995a90a8ca72026-03-03Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
Acid Controller Original StrengthFAMOTIDINEWalgreen Company98c6ddc9-8103-40b3-a145-ffbe3374ab6c2026-03-03WarningsName fallback
generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

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