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 2 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEFamily Dollar Stores, LLC4dc7c2c4-83c7-608d-e063-6294a90a90eb2026-06-23WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEUnit Dose Solutions, Inc.54d93bf1-8f9a-981b-e063-6394a90a0fde2026-06-22Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINETWIN MED LLC795afb99-a3f4-4ffc-a905-2f84f3d86e4c2026-06-16WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINETWIN MED LLC6d97c60e-e39d-4541-ab49-d0fe3b3fa8402026-06-16WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINESafecor Health, LLC1b5cb132-d28f-4fbe-91f5-dc04f9a551d12026-06-11Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.e59a2c97-19c7-485c-bb1b-272ddb9ae0532026-06-09Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.32fd4101-15cb-411e-8b9d-270ec0592c6e2026-06-08Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACY31cdc900-fe17-2d5f-e063-6294a90a0fda2026-06-08Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINESagent Pharmaceuticals9710995d-b518-40ce-bc2b-8b5dcf002c312026-06-06Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
acid reliefFAMOTIDINERite Aid Corporation8c6d5419-088b-4b3e-80b8-2a0d06926ff12026-06-03WarningsName fallback
generic name: FAMOTIDINE
ACID REDUCERFAMOTIDINEHyVee Inc381db08e-5756-4255-8202-1d8e6a1cf0382026-06-03WarningsName fallback
generic name: FAMOTIDINE
acid reliefFAMOTIDINERite Aid Corporation34034d16-dc3b-436d-8ec8-84b3c1f8e48a2026-06-03WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINESt. Mary's Medical Park Pharmacyf175822d-7ca4-fa33-e053-2995a90ac3102026-06-02Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEProficient Rx LP68d21d95-9603-4e68-855a-bfc65b1b58c32026-06-01Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEA-S Medication Solutionse53928f3-5181-490b-acfb-be8d4cea60a92026-05-29Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEA-S Medication Solutions05b47b1d-f7f3-4dae-9b22-d43d2a7cfaef2026-05-29Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
acid reliefFAMOTIDINERite Aid Corporation9826dd26-5592-4f96-9274-005ef9462cb42026-05-27WarningsName fallback
generic name: FAMOTIDINE
CareOne Acid ReliefFAMOTIDINEAmerican Sales Company206f5483-7de1-4bc3-af27-190e211bcb952026-05-21WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepackcf2cd30e-9a0f-4b63-975c-5b551691cda92026-05-21Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEA-S Medication Solutionsd0558e97-3bc3-4a1e-9248-1959b03440232026-05-19Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

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