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 5 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINERedpharm Drug44f3f63d-4522-91e4-e063-6394a90a6d1b2025-12-02Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAjanta Pharma USA Inc.a88e7069-230c-4105-ade0-a98968e186712025-11-30Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINENovadoz Pharmaceuticals LLC74a24590-a0b6-4607-8e67-9fadce53389b2025-11-12Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAvPAK85c7d20d-3dec-b918-4c1d-8ca1db214e482025-11-11Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
famotidineFAMOTIDINEChartwell RX, LLC70714491-1368-4824-98af-03fda52139a92025-11-04Warnings, Adverse reactionsName fallback
brand name: famotidine
generic name: FAMOTIDINE
Heartburn ReliefFAMOTIDINEShield Pharmaceuticals Corpa12ec91d-244f-45c5-8590-d1e4485fe3612025-10-31WarningsName fallback
generic name: FAMOTIDINE
careone acid reliefFAMOTIDINERetail Business Services, LLC8f654234-b25d-47d6-b1f8-f7f3535697952025-10-30WarningsName fallback
generic name: FAMOTIDINE
Acid ControllerFAMOTIDINEH E B8aac5a0d-074b-4cf4-ab10-549e1ed09e2f2025-10-30WarningsName fallback
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEBryant Ranch Prepack7cef62ab-1740-4d0f-b6ea-fda783e1c1972025-10-23Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.002875d2-8c30-2d2e-e063-6294a90ae01e2025-10-22Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.66f0bf15-ff35-426a-b40c-0d0da79d08612025-10-16Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.09ef39a4-c6b3-4395-8211-3f551dc448302025-10-16Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.5798d282-ce83-49aa-bc33-13203f2b52852025-10-15Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.2f5ec69d-926c-47a2-be47-8fef2e0ff2072025-10-14Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepackc133a9e1-ca48-4ee2-8768-01f44f5dd5112025-10-14Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEA-S Medication Solutions3c32f8e2-f54a-422d-9c25-68692ea090012025-10-10Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a3b50576-cd40-4f7e-9506-bd0a619884242025-10-09Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
Zantac 360 Cool MintFAMOTIDINEChattem, Inc.19fe7c6e-243c-4005-a63a-f8cac1ce55c82025-09-30WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepacke034546b-28cb-41aa-9441-655cdb9665542025-09-29Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
equaline heartburn preventionFAMOTIDINEUnited Natural Foods, Inc. dba UNFIf40f1dcf-249a-4ccb-bdfc-acff49dd4a152025-09-25WarningsName fallback
generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

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