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 11 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEAlembic Pharmaceuticals Limited7c0f3fa5-0a44-4a98-bc43-8bff8e95c4622024-10-31Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
Acid ReducerFAMOTIDINEAllegiant Health5c6c6665-cb0a-41d1-af28-85b4f061bd1b2024-10-30WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAmerican Health Packaging3a583080-6771-4246-a221-2491e9e5d8af2024-09-24Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEGolden State Medical Supply, Inc.f67bcbc7-952c-61c0-e053-2a95a90a6fa62024-09-20Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepack67a6e7f3-04d6-426c-b952-7677a84ace4d2024-09-06Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepack3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb2024-09-06Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepack92a75aa6-3c63-4c98-be8e-dcd03affc10b2024-09-05Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepack81f24752-3474-3013-0013-5570c8e7baf72024-09-05Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepack82930f64-4556-491f-96cc-270be9e3589a2024-09-05Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEProficient Rx LP4adb4864-04ac-4cb1-96c2-6196a30ac6402024-09-01Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINECarlsbad Technology, Inca8b5c855-053d-4295-8f57-1a96a6ccaa922024-08-23Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepack72a97532-9a79-4cbf-b9d0-22ce1f21468d2024-08-23Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEBryant Ranch Prepack077bb160-e616-4863-bdde-989140f99e1c2024-08-23Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepack8dc075fe-a3e5-4710-8c19-73558a8c5f092024-08-23Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEA-S Medication Solutions66878006-8913-4c91-8038-901142cf520d2024-08-21Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBaxter Healthcare Corporation97c33213-f415-4718-8466-9aa50371af702024-08-20Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINENuCare Pharmaceuticals, Inc.4b820924-24ad-4a2f-e054-00144ff88e882024-07-19Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINENuCare Pharmaceuticals,Inc.b556d1a8-4155-50cf-e053-2995a90a9b142024-07-17Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
Original strength heartburn preventionFAMOTIDINEKROGER COMPANYea1c2838-acbd-18e0-e053-2a95a90a35222024-07-08WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEContract Pharmacal Corp.273deac8-c2b0-423f-8662-4f16d91df2162024-07-04Warnings, 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.