FDA.reportPublic FDA data

Application 215925

Type
ANDA
Sponsor
TORRENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFEN AND FAMOTIDINEFAMOTIDINE; IBUPROFENTABLET;ORAL26.6MG;800MGNoNo

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

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
A215925-001IBUPROFEN AND FAMOTIDINEFAMOTIDINE; IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-18

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 UTC2026-02A215925-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORAL2024-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215925-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORAL2024-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215925-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORAL2024-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215925-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORAL2024-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215925-001FAMOTIDINE AND IBUPROFEN26.6MG;800MGTABLET / ORAL2024-03-188072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215925-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORAL2024-03-18a50c72e98297…

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 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAscend Laboratories, LLC4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC548c705e-4094-fc6f-e063-6394a90a34262026-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and Famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC4ee3e849-2197-8883-e063-6394a90a17482026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEREMEDYREPACK INC.b969bb72-66de-47ce-9d77-64d029e1a5c92026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC3ff33400-30e8-87fa-e063-6394a90a7f5c2025-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: IBUPROFEN AND FAMOTIDINE
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPreferred Pharmaceuticals Inc.e2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f2025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC397f1f23-10c2-569e-e063-6394a90a71642025-07-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAurobindo Pharma Limited21688404-41fb-487e-8ba0-aea4431a42fa2025-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEZydus Lifesciences Limited24204938-0989-42ad-8ad8-89979e62d7002025-05-28Name fallback
brand name: Ibuprofen and Famotidine
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEViona Pharmaceuticals Inc66524c84-35bc-4e7f-897a-f63fa4bca4322025-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and Famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC2cf7412a-7f94-e39f-e063-6294a90a5bc22025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAsclemed USA, Inc.41123df3-97ac-4c4f-9a89-f76ec03898bb2025-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPar Health USA, LLCb6895176-efb1-472e-8b6f-2987e8e676842024-10-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEBryant Ranch Prepackee69d3cb-dc95-410c-a7c8-6623073a923d2024-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC1d625438-34dc-fbba-e063-6294a90afd2f2024-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen and famotidine
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINECamber Pharmaceuticals, Inc.7dc158a2-fdfa-4a5f-8c28-0ce5650991db2024-07-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: IBUPROFEN AND FAMOTIDINE
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEAdvanced Rx Pharmacy of Tennessee, LLC16c8b0db-37d0-99d9-e063-6394a90ac31b2024-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: IBUPROFEN AND FAMOTIDINE
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEAscent Pharmaceuticals, Inc.03733e49-7db4-4d98-b363-d0d23686ec722023-03-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: IBUPROFEN AND FAMOTIDINE