FDA.reportPublic FDA data

Application 217432

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINEINJECTABLE;INJECTION10MG/MLNoNo

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
A217432-001FAMOTIDINEFAMOTIDINE10MG/MLINJECTABLE / INJECTIONAP2026-05-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217432-001AP

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 22:38:342026-08A217432-001FAMOTIDINE10MG/MLINJECTABLE / INJECTIONAP2026-05-1284e616aacf4f…
2026-08-18 06:07:402026-07A217432-001FAMOTIDINE10MG/MLINJECTABLE / INJECTIONAP2026-05-12caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217432-001FAMOTIDINE10MG/MLINJECTABLE / INJECTIONAP2026-05-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217432-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A217432-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217432-001AP1a50c72e98297…

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 1 of 15 · 292 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEREMEDYREPACK INC.669fbd46-cae5-4477-884e-8eca893d2e052026-09-09Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAurohealth LLC5b161f25-c578-4ff4-a931-ff3a1e681c502026-09-04WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
ACID REDUCERFAMOTIDINEAmazon.com Services LLCd5823283-aa97-451e-ba0d-69f0e79c85142026-08-31WarningsName fallback
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.9c5dce17-1865-4aa6-89f6-24dd55b5f06c2026-08-27Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.599642c8-51cd-4220-e063-6394a90a5e202026-08-24Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEMajor Pharmaceuticals3e6d167f-91e4-4122-911d-d3da66386f442026-08-20Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.cd95271c-cf39-47fb-97a6-f6ee1e619e4a2026-08-12Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
heartburn preventionFAMOTIDINEKroger Companyc97851ef-7b49-4f6c-b165-147555db101a2026-08-11WarningsName fallback
generic name: FAMOTIDINE
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf347f870-1da4-4a77-8c20-63b703d240712026-08-05WarningsName fallback
generic name: FAMOTIDINE
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7e5f9492-1d58-47a3-aac6-c41c81b348d52026-08-03WarningsName fallback
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a0f38398-4d34-4ecc-8a6a-37732adaaad32026-07-30Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAscend Laboratories, LLCb2228be0-472b-4e47-9910-af0bf12fde772026-07-27Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEHAWAII REPACK, INC.eec89230-47fc-4139-a370-b4f9e225e8c02026-07-13Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAdvanced Rx of Tennessee, LLC5648ca13-1add-56ec-e063-6294a90a6f292026-07-10Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
CareOne Acid ReliefFAMOTIDINEAmerican Sales Companyed474c9d-c08b-4f52-8b24-5887978e42752026-07-01WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINERedpharm Drug55730918-d9e8-eaad-e063-6394a90aeda22026-06-30Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
Zantac 360FAMOTIDINESelect Consumer Group LLC529cef2d-e6cc-3b37-e063-6294a90aff592026-06-27WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINESportpharm LLC4421ceb7-a114-436c-871a-7bc5444f81542026-06-26Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINERISING PHARMA HOLDINGS, INC.c013654e-9cad-4c59-8fea-b00ae1567c182026-06-24Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINECVS Pharmacy, Inc.7357f67e-0fc6-4555-aa8b-1df09cba9feb2026-06-24WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE