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 13 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepcid ACFAMOTIDINELil' Drug Store Products, Inc.14406cd8-468b-403d-9be2-43decd3042142024-01-09WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEA-S Medication Solutionsd8cfa644-7cad-41b9-82a0-242a783fcbc82023-12-18Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEA-S Medication Solutions2bde8e1d-078f-4ba1-9ccb-29de6e36d8c42023-12-18Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEA-S Medication Solutions99de67a5-a566-46c9-bc80-dc6fc03be11f2023-11-02Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEA-S Medication Solutionsae3646c7-76fc-473d-b20b-67d3c6ac0b752023-10-25Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEZydus Pharmaceuticals USA Inc.b165979b-7ed0-423e-9aeb-2e061df0cd452023-10-06Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEANI Pharmaceuticals, Inc.8e41e259-b161-4f11-a6f7-14e6b60885b82023-10-02Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINENorthStar Rx LLC04aaf296-f136-29d7-e063-6294a90affe12023-09-07Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEAscend Laboratories, LLCea50552f-f9b9-467f-a925-62ff027df6072023-08-25Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINECamber Pharmaceuticals, Inc.8e7f9c85-d165-47c7-8950-b22adcd6cece2023-08-23Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEA-S Medication Solutions74ff64f2-d882-411f-bac8-29dfa4cb4f102023-08-09Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
Maximum Strength Acid ControllerFAMOTIDINEBETTER LIVING BRANDS LLC.f2c031b4-de86-3a8e-e053-2a95a90a21e02023-07-30WarningsName fallback
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEBiocon Pharma Inc.ea7287a4-75e0-39d2-5b2e-b72b7cb386b92023-05-21Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEMedical Purchasing Solutions, LLCbbeffa0a-2bc7-fea4-e053-2a95a90ac5112023-05-08Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEMedical Purchasing Solutions, LLCb6214fc9-a274-ef45-e053-2a95a90ae43a2023-05-04Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBluePoint Laboratoriesbefd8d44-c6f7-eca2-e053-2995a90a714b2023-03-23WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEProficient Rx LPfe21daca-ac48-4b46-9cb3-9a69af0c6a842023-03-01Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEZydus Pharmaceuticals USA Inc.a8010e10-68fd-455f-968f-d62a1c3e0ffd2022-12-02Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEFresenius Kabi USA, LLCaeb27cea-1ff7-4a6e-93f1-d4c4dac5faa72022-11-08Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEFresenius Kabi USA, LLC5995d726-f3f8-4c2d-af19-1b12e3f769c62022-10-20Warnings, 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.