Home Applications 075400 Application 075400
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FAMOTIDINE FAMOTIDINE TABLET;ORAL 10MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075400-001 FAMOTIDINE FAMOTIDINE 10MG TABLET / ORAL 2005-03-18
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 f41ea6bd6efb…
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 2 · 21 matching rows.
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 2 · 103 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0141 good sense acid reducer Famotidine L. Perrigo Company ANDA Current 0113-0141 good sense acid reducer Famotidine L. Perrigo Company ANDA Current 0113-0141 good sense acid reducer Famotidine L. Perrigo Company ANDA Current 0113-7141 basic care acid reducer Famotidine L. Perrigo Company ANDA Current 0113-7141 basic care acid reducer Famotidine L. Perrigo Company ANDA Current 0113-7141 basic care acid reducer Famotidine L. Perrigo Company ANDA Current 0363-0141 Acid Controller Famotidine Walgreen Company ANDA Current 0363-0141 Acid Controller Famotidine Walgreen Company ANDA Current 0363-0141 Acid Controller Famotidine Walgreen Company ANDA Current 0363-0141 Acid Controller Famotidine Walgreen Company ANDA Current 0363-0141 Acid Controller Famotidine Walgreen Company ANDA Current 0904-5529 heartburn relief Famotidine Major Pharmaceuticals ANDA Current 0904-5529 heartburn relief Famotidine Major Pharmaceuticals ANDA Current 0904-5529 heartburn relief Famotidine Major Pharmaceuticals ANDA Current 0904-5529 heartburn relief Famotidine Major Pharmaceuticals ANDA Current 11673-031 up and up famotidine Famotidine Target Corporation ANDA Current 11673-031 up and up famotidine Famotidine Target Corporation ANDA Current 11673-031 up and up famotidine Famotidine Target Corporation ANDA Current 11673-031 up and up famotidine Famotidine Target Corporation ANDA Current 11673-031 up and up famotidine Famotidine Target Corporation ANDA Current 11822-0141 acid reducer Famotidine Rite Aid Corporation ANDA Current 11822-0141 acid reducer Famotidine Rite Aid Corporation ANDA Current 11822-0141 acid reducer Famotidine Rite Aid Corporation ANDA Current 11822-0141 acid reducer Famotidine Rite Aid Corporation ANDA Current 21130-249 signature care acid controller Famotidine Safeway ANDA Current 21130-249 signature care acid controller Famotidine Safeway ANDA Current 21130-249 signature care acid controller Famotidine Safeway ANDA Current 21130-249 signature care acid controller Famotidine Safeway ANDA Current 21130-249 signature care acid controller Famotidine Safeway ANDA Current 30142-141 heartburn prevention Famotidine Kroger Company ANDA Current 30142-141 heartburn prevention Famotidine Kroger Company ANDA Current 36800-141 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-141 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-141 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-141 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-141 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-141 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 37205-614 leader acid reducer Famotidine Cardinal Health ANDA Current 37205-614 leader acid reducer Famotidine Cardinal Health ANDA Current 37205-614 leader acid reducer Famotidine Cardinal Health ANDA Current 37808-301 acid controller Famotidine H E B ANDA Current 37808-301 acid controller Famotidine H E B ANDA Current 37808-301 acid controller Famotidine H E B ANDA Current 37808-301 acid controller Famotidine H E B ANDA Current 41163-313 equaline heartburn prevention Famotidine Supervalu Inc ANDA Current 41163-313 equaline heartburn prevention Famotidine Supervalu Inc ANDA Current 41163-313 equaline heartburn prevention Famotidine Supervalu Inc ANDA Current 41163-313 equaline heartburn prevention Famotidine Supervalu Inc ANDA Current 41190-141 ShopRite Acid Reducer Famotidine Wakefern Food Corporation ANDA Current 41190-141 ShopRite Acid Reducer Famotidine Wakefern Food Corporation ANDA Current 41250-141 acid reducer Famotidine Meijer Distribution Inc ANDA Current 41250-141 acid reducer Famotidine Meijer Distribution Inc ANDA Current 41250-493 heartburn relief famotidine Meijer Distribution Inc ANDA Current 41250-493 heartburn relief famotidine Meijer Distribution Inc ANDA Current 41250-493 heartburn relief famotidine Meijer Distribution Inc ANDA Current 41520-901 CareOne Acid Reducer Famotidine American Sales Company ANDA Current 41520-901 CareOne Acid Reducer Famotidine American Sales Company ANDA Current 41520-901 CareOne Acid Reducer Famotidine American Sales Company ANDA Current 41520-901 CareOne Acid Reducer Famotidine American Sales Company ANDA Current 46122-394 Good Neighbor Pharmacy Acid Reducer Famotidine Amerisource Bergen ANDA Current 46122-394 Good Neighbor Pharmacy Acid Reducer Famotidine Amerisource Bergen ANDA Current 46122-394 Good Neighbor Pharmacy Acid Reducer Famotidine Amerisource Bergen ANDA Current 46122-394 Good Neighbor Pharmacy Acid Reducer Famotidine Amerisource Bergen ANDA Current 49035-507 Equate Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49035-507 Equate Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49035-507 Equate Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49035-507 Equate Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49348-128 sunmark acid reducer Famotidine Strategic Sourcing Services LLC ANDA Current 49348-128 sunmark acid reducer Famotidine Strategic Sourcing Services LLC ANDA Current 49348-128 sunmark acid reducer Famotidine Mckesson ANDA Current 49348-128 sunmark acid reducer Famotidine Strategic Sourcing Services LLC ANDA Current 49738-201 smart sense famotidine Famotidine Kmart Corporation ANDA Current 55910-141 dg health heartburn prevention Famotidine Dolgencorp, LLC ANDA Current 55910-141 dg health heartburn prevention Famotidine Dolgencorp, LLC ANDA Current 55910-141 dg health heartburn prevention Famotidine Dolgencorp, LLC ANDA Current 55910-141 dg health heartburn prevention Famotidine Dolgencorp, LLC ANDA Current 55910-141 dg health heartburn prevention Famotidine Dolgencorp, LLC ANDA Current 56062-141 acid reducer Famotidine Publix Super Markets Inc ANDA Current 56062-141 acid reducer Famotidine Publix Super Markets Inc ANDA Current 56062-141 acid reducer Famotidine Publix Super Markets Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30873 ORIG 2003-04-10