FDA.reportPublic FDA data

Application 090283

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090283-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2009-11-17
A090283-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2009-11-17

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-1784e616aacf4f…
2026-09-14 22:38:342026-08A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-1784e616aacf4f…
2026-08-18 06:07:402026-07A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-1774a2ff9319b5…

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 8 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINECVS Pharmacy, Inc.c4e35c7e-5c2f-4252-e053-2a95a90a82682025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINECVS Pharmacy, Inc.479a1437-a212-49d9-b272-758c0e5b72032025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBest Choicefadbd056-6510-f864-e053-6294a90aa67b2025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAurohealth LLCf2b911c7-ce24-4d3d-8fb6-c34980191f402025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAurohealth LLC6d0d8839-0680-45f6-96db-2d8edc9d46822025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWal-Mart Stores, Inc.43fb44ea-07a1-4df9-8b4a-b2249757208e2025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAmerisource Bergend8df03ab-7c5c-4c8b-a3fb-6c6081e081e72025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWALGREEN CO.2766ffe7-2f1c-48c8-8f67-0a2819dcc3be2025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWALGREEN CO.d0f74e78-7afb-49c2-e053-2a95a90a31dc2025-04-22WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINENovadoz Pharmaceuticals LLC21953598-e7ec-45c2-8fca-05550a1ddf382025-04-10Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
acid reducerFAMOTIDINECVS Pharmacy373f5e28-e9e2-4af7-8a27-29b5d8f28b502025-04-07WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWestminster Pharmaceuticals, LLCc0e15f57-ab20-4030-b1d1-6aff33be7d762025-04-07Warnings, Adverse reactionsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINELEADER/ CARDINAL HEALTH 110, INC.cdd509c4-331b-4aee-935c-dfc44d5943ed2025-04-05WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWALGREEN CO.e9ded705-85c7-1380-e053-2995a90a68ec2025-04-05WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBi-Mart9974aa5e-e03f-4459-934a-ece27a8307462025-04-01WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FAMOTIDINEFAMOTIDINEBryant Ranch Prepacka24e8f45-6ace-4a81-8005-c23a55dadd9a2025-03-31Warnings, Adverse reactionsName fallback
brand name: FAMOTIDINE
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBest Choicefadb9d53-4cc6-83d6-e053-6394a90aa2e32025-03-28WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAmerisource Bergena5d88925-efca-4240-9eb5-6a9d0ac7a67e2025-03-28WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEBetter Living Brands LLCf6f07e25-2b31-b0c4-e053-6294a90a8ffb2025-03-28WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE
FamotidineFAMOTIDINEHARRIS TEETER, LLCe49e087c-ee20-3174-e053-2995a90a1d092025-03-28WarningsName fallback
brand name: Famotidine
generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0036FamotidineFamotidineWalgreen CompanyANDACurrent
15127-370FamotidineFamotidineSelect BrandANDACurrent
37012-036FamotidineFamotidineShopko Stores Operating Co., LLCANDACurrent
37808-036FamotidineFamotidineHEBANDACurrent
46122-168FamotidineFamotidineAMERISOURCE BERGENANDACurrent
46122-168FamotidineFamotidineAMERISOURCE BERGENANDACurrent
51660-035FamotidineFamotidineOhm Laboratories Inc.ANDACurrent
51660-036Famotidine - Acid ControllerFamotidineOhm Laboratories Inc.ANDACurrent
53943-036FamotidineFamotidineDISCOUNT DRUG MARTANDACurrent
53943-037FamotidineFamotidineDISCOUNT DRUG MARTANDACurrent
54473-203Calmicid ACLoratadineMelaleuca, Inc.ANDACurrent
54473-203Calmicid ACLoratadineMelaleuca, Inc.ANDACurrent
55315-035FamotidineFamotidineFred's Inc.ANDACurrent
57451-5065FamotidineFamotidineIpca Laboratories LimitedANDACurrent
57451-5066FamotidineFamotidineIpca Laboratories LimitedANDACurrent
57896-767FamotidineFamotidineGeri-Care Pharmaceutical CorpANDACurrent
57896-769FamotidineFamotidineGERI-CARE PHARMACEUTICAL CORPANDACurrent
61715-063FamotidinefamotidineKinrayANDACurrent
61715-064FamotidinefamotidineKinrayANDACurrent
63868-486FamotidineFamotidineChain Drug Marketing Association Inc.ANDACurrent
63868-714FamotidineFamotidineChain Drug Marketing Association Inc.ANDACurrent
63941-035FamotidineFamotidineValu Merchandisers CompanyANDACurrent
63941-036FamotidineFamotidineValu Merchandisers CompanyANDACurrent
67091-241Famotidine - Acid ControllerFamotidineWinCo Foods, LLCANDACurrent
67091-242Famotidine - Acid ControllerFamotidineWinCo Foods, LLCANDACurrent
68016-008Premier Value FamotidineFamotidinePremier ValueANDACurrent
68016-008Premier Value FamotidineFamotidinePremier ValueANDACurrent
68016-010Premier Value FamotidineFamotidinePremier ValueANDACurrent
68016-010Premier Value FamotidineFamotidinePremier ValueANDACurrent