FDA.reportPublic FDA data

Application 218461

Type
ANDA
Sponsor
GRAVITI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINETABLET;ORAL10MGNoNo
002FAMOTIDINEFAMOTIDINETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218461-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2024-03-14
A218461-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2024-03-14

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
2026-02-19 14:30 UTC2026-02A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-148072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-14a50c72e98297…

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 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Signature Care Acid Controller maximum strengthFAMOTIDINESafewayca5edcf8-1ed2-403a-a01b-0deb692bee0c2026-06-30WarningsName fallback
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
FamotidineFAMOTIDINECVS Pharmacy, Inc.7357f67e-0fc6-4555-aa8b-1df09cba9feb2026-06-24WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEFamily Dollar Stores, LLC4dc7c2c4-83c7-608d-e063-6294a90a90eb2026-06-23WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEUnit Dose Solutions, Inc.54d93bf1-8f9a-981b-e063-6394a90a0fde2026-06-22Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINETWIN MED LLC795afb99-a3f4-4ffc-a905-2f84f3d86e4c2026-06-16WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINETWIN MED LLC6d97c60e-e39d-4541-ab49-d0fe3b3fa8402026-06-16WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINESafecor Health, LLC1b5cb132-d28f-4fbe-91f5-dc04f9a551d12026-06-11Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.e59a2c97-19c7-485c-bb1b-272ddb9ae0532026-06-09Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.32fd4101-15cb-411e-8b9d-270ec0592c6e2026-06-08Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACY31cdc900-fe17-2d5f-e063-6294a90a0fda2026-06-08Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINESagent Pharmaceuticals9710995d-b518-40ce-bc2b-8b5dcf002c312026-06-06Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
acid reliefFAMOTIDINERite Aid Corporation8c6d5419-088b-4b3e-80b8-2a0d06926ff12026-06-03WarningsName fallback
generic name: FAMOTIDINE