FDA.reportPublic FDA data

Application 075708

Type
ANDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINE PRESERVATIVE FREEFAMOTIDINEINJECTABLE;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
A075708-001FAMOTIDINE PRESERVATIVE FREEFAMOTIDINE10MG/MLINJECTABLE / INJECTION2001-04-16

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075708-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTION2001-04-16f41ea6bd6efb…

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 9 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINECVS Pharmacy, Inc.c4e1ef3d-7391-66f5-e053-2995a90abc002025-03-28WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEHarris Teeterbc548297-7646-4dbf-bfc5-65f2bc6296762025-03-26WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAurohealth LLC27ecf5c1-202a-44cf-94f9-d7fefa027e1e2025-03-15WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWALGREEN CO.316e3815-6ae1-47c3-8a75-fd57f8434a6f2025-03-15WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEWal-Mart Stores, Inc.018b02e8-1005-4736-a4fc-962881f52adf2025-03-15WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAurohealth LLC756c7234-6a63-4b1b-be36-2b1ed09e67a02025-03-15WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEAurobindo Pharma Limitedb0798337-1a73-415e-8416-613984ce5c652025-03-04Warnings, Adverse reactionsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINEGolden State Medical Supply, Inc.c72fad2e-3ffb-4f83-e053-2a95a90a3f9c2025-02-18Warnings, Adverse reactionsName fallback
generic name: FAMOTIDINE
heartburn reliefFAMOTIDINEMeijer Distribution Inc05c03fd8-abc8-47f7-868c-895b9a38c5b32025-02-17WarningsName fallback
generic name: FAMOTIDINE
acid reducerFAMOTIDINEPublix Super Markets Inca3ba9983-6747-45b2-b270-4ac1fb9d6e402025-02-17WarningsName fallback
generic name: FAMOTIDINE
acid controller original strengthFAMOTIDINECVS Pharmacyc7cb4e19-3442-45d2-b60a-87d4beea862a2025-02-13WarningsName fallback
generic name: FAMOTIDINE
heartburn reliefFAMOTIDINEMeijer Distribution Inc263ee489-fc3f-4578-b3a5-44f6d77578982025-02-13WarningsName fallback
generic name: FAMOTIDINE
kirkland signature acid controllerFAMOTIDINECostco Wholesale Companyd5d96078-ba87-4593-b15b-b7a646a8ab102025-02-12WarningsName fallback
generic name: FAMOTIDINE
FamotidineFAMOTIDINELEADER/ Cardinal Health 110, Inc.287525d8-83ef-7110-e063-6294a90ad3732025-02-11WarningsName fallback
generic name: FAMOTIDINE
Acid ControllerFAMOTIDINEH E Bcbe72270-b172-4662-9b9b-557e8cf53ffe2025-02-11WarningsName fallback
generic name: FAMOTIDINE
dg health heartburn prevention original strengthFAMOTIDINEDolgencorp, LLCf5c0ff75-77da-443c-a510-9c6a065ddc6c2025-02-11WarningsName fallback
generic name: FAMOTIDINE
foster and thrive acid reducerFAMOTIDINEStrategic Sourcing Services LLC9ff8539f-cdcd-4823-8baa-10a249c9220d2025-02-10WarningsName fallback
generic name: FAMOTIDINE
basic care acid reducerFAMOTIDINEAmazon.com Services LLC52e3b2f5-f3b9-4f4e-a70f-322eb04e6e8a2025-02-10WarningsName fallback
generic name: FAMOTIDINE
signature care acid controllerFAMOTIDINESafewayadbf2c58-cd1c-4444-b133-21a18a3489312025-02-10WarningsName fallback
generic name: FAMOTIDINE
basic care acid reducerFAMOTIDINEAmazon.com Services LLC0983cef7-b8b6-4ed9-a01e-c699fa6d2d062025-02-10WarningsName fallback
generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30995ORIG2004-06-04