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 15 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEAphena Pharma Solutions - Tennessee, LLC46c6d243-eefc-40ca-8bd4-4c89456f635f2021-05-18Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBluePoint Laboratories8c7ca3cc-ff90-42a7-9218-554cf15348a32021-04-13Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEDr.Reddy's Laboratories Limited06d286ce-14b3-4b66-8b42-ac4a10a0fc902020-11-17Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAphena Pharma Solutions - Tennessee, LLCb1839d23-20f4-4651-a7d2-8bc3a75839172020-07-06Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEProficient Rx LP1e2003d4-09a3-4cc8-af3d-93d29b9123c02020-07-01Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEProficient Rx LP92048836-e692-4ce1-93f4-88b00acabcde2019-11-01Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
heartburn relief original strengthFAMOTIDINEProficient Rx LP5567aaaf-b4f2-4604-b841-c9447e77256c2019-10-01WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINETeva Pharmaceuticals USA, Inc.4c6f4f9e-f3f5-4ecf-9f40-887e037e88472019-01-01Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINELupin Pharmaceuticals,Inc.a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f82017-11-21Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

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