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 42.

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
2026-08-18 06:07:402026-07A218461-001FAMOTIDINE10MGTABLET / ORAL2024-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A218461-002FAMOTIDINE20MGTABLET / ORAL2024-03-14caaa826d4ba7…
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 2 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ACID REDUCERFAMOTIDINEHyVee Inc381db08e-5756-4255-8202-1d8e6a1cf0382026-06-03WarningsName fallback
generic name: FAMOTIDINE
acid reliefFAMOTIDINERite Aid Corporation34034d16-dc3b-436d-8ec8-84b3c1f8e48a2026-06-03WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINESt. Mary's Medical Park Pharmacyf175822d-7ca4-fa33-e053-2995a90ac3102026-06-02Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEProficient Rx LP68d21d95-9603-4e68-855a-bfc65b1b58c32026-06-01Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEA-S Medication Solutionse53928f3-5181-490b-acfb-be8d4cea60a92026-05-29Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEA-S Medication Solutions05b47b1d-f7f3-4dae-9b22-d43d2a7cfaef2026-05-29Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
acid reliefFAMOTIDINERite Aid Corporation9826dd26-5592-4f96-9274-005ef9462cb42026-05-27WarningsName fallback
generic name: FAMOTIDINE
CareOne Acid ReliefFAMOTIDINEAmerican Sales Company206f5483-7de1-4bc3-af27-190e211bcb952026-05-21WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepackcf2cd30e-9a0f-4b63-975c-5b551691cda92026-05-21Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEA-S Medication Solutionsd0558e97-3bc3-4a1e-9248-1959b03440232026-05-19Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBryant Ranch Prepackdb3af7cc-efc6-4934-acff-8bb2d31fe8292026-05-19Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
good sense acid reducerFAMOTIDINEL. Perrigo Companycc77f6ff-a534-4731-b971-4912808408992026-05-18WarningsName fallback
generic name: FAMOTIDINE
Good Sense Acid ReducerFAMOTIDINEL. Perrigo Company39cb0f15-d177-46eb-a549-7acb885fbf072026-05-11WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINECardinal Health 107, LLC5d515c2a-dac9-42d8-aede-66d28a427dbc2026-05-11Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACYfebe39b1-9212-a281-e053-6394a90a1a9f2026-05-01Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINECardinal Health 107, LLCcdd5dfb7-4efb-4235-8023-5ce145c090382026-04-27Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE