Home Applications 077351 Application 077351
Type ANDA
Sponsor PERRIGO R AND D Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG 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 A077351-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2006-09-25
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 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 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 3 of 3 · 41 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 · 158 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0194 Good Sense Acid Reducer Famotidine L. Perrigo Company ANDA Current 0113-0194 Good Sense Acid Reducer Famotidine L. Perrigo Company ANDA Current 0113-0194 Good Sense Acid Reducer Famotidine L. Perrigo Company ANDA Current 0113-0194 Good Sense Acid Reducer Famotidine L. Perrigo Company ANDA Current 0113-0194 Good Sense Acid Reducer Famotidine L. Perrigo Company ANDA Current 0113-7194 Basic Care famotidine Famotidine L. Perrigo Company ANDA Current 0113-7194 Basic Care famotidine Famotidine L. Perrigo Company ANDA Current 0363-0701 Acid Controller Famotidine Walgreen Company ANDA Current 0363-0701 Acid Controller Famotidine Walgreen Company ANDA Current 0363-0701 Acid Controller Famotidine Walgreen Company ANDA Current 0363-0701 Acid Controller Famotidine Walgreen Company ANDA Current 0363-0701 Acid Controller Famotidine Walgreen Company ANDA Current 0363-1203 acid controller famotidine Walgreen Company ANDA Current 0536-1298 Rugby Famotidine Famotidine Rugby Laboratories ANDA Current 0536-1298 Rugby Famotidine Famotidine Rugby Laboratories ANDA Current 0904-5780 Major Heartburn Relief Famotidine Major Pharmaceuticals ANDA Current 0904-5780 Major Heartburn Relief Famotidine Major Pharmaceuticals ANDA Current 0904-5780 Major Heartburn Relief Famotidine Major Pharmaceuticals ANDA Current 0904-5780 Major Heartburn Relief Famotidine Major Pharmaceuticals ANDA Current 10202-194 7 Select Acid Controller Famotidine 7-Eleven ANDA Current 10202-194 7 Select Acid Controller Famotidine 7-Eleven ANDA Current 11673-061 up and up famotidine Famotidine Target Corporation ANDA Current 11673-061 up and up famotidine Famotidine Target Corporation ANDA Current 11673-061 up and up famotidine Famotidine Target Corporation ANDA Current 11673-061 up and up famotidine Famotidine Target Corporation ANDA Current 11673-061 up and up famotidine Famotidine Target Corporation ANDA Current 11673-414 up and up famotidine famotidine Target Corporation ANDA Current 11822-0194 acid reducer Famotidine Rite Aid Corporation ANDA Current 11822-0194 acid reducer Famotidine Rite Aid Corporation ANDA Current 11822-0194 acid reducer Famotidine Rite Aid Corporation ANDA Current 11822-0194 acid reducer Famotidine Rite Aid Corporation ANDA Current 11822-1014 acid relief famotidine Rite Aid Corporation ANDA Current 21130-777 Signature Care Acid Controller Famotidine Safeway ANDA Current 21130-777 Signature Care Acid Controller Famotidine Safeway ANDA Current 21130-777 Signature Care Acid Controller Famotidine Safeway ANDA Current 21130-777 Signature Care Acid Controller Famotidine Safeway ANDA Current 24385-385 Good Neighbor Pharmacy Acid Reducer Famotidine Amerisource Bergen ANDA Current 24385-385 Good Neighbor Pharmacy Acid Reducer Famotidine Amerisource Bergen ANDA Current 24385-385 Good Neighbor Pharmacy Acid Reducer Famotidine Amerisource Bergen ANDA Current 24385-385 Good Neighbor Pharmacy Acid Reducer Famotidine Amerisource Bergen ANDA Current 30142-194 heartburn prevention Famotidine Kroger Company ANDA Current 30142-194 heartburn prevention Famotidine Kroger Company ANDA Current 30142-194 heartburn prevention Famotidine Kroger Company ANDA Current 30142-194 heartburn prevention Famotidine Kroger Company ANDA Current 36800-194 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-194 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-194 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-194 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-194 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 36800-194 TopCare Acid Reducer Famotidine Topco Associates LLC ANDA Current 37012-194 Acid Controller Famotidine Shopko Stores Operating Co., LLC ANDA Current 37012-194 Acid Controller Famotidine Shopko Stores Operating Co., LLC ANDA Current 37205-861 Leader Acid Reducer Famotidine Cardinal Health ANDA Current 37205-861 Leader Acid Reducer Famotidine Cardinal Health ANDA Current 37205-861 Leader Acid Reducer Famotidine Cardinal Health ANDA Current 37808-042 Acid Controller Famotidine H E B ANDA Current 37808-042 Acid Controller Famotidine H E B ANDA Current 37808-042 Acid Controller Famotidine H E B ANDA Current 37808-042 Acid Controller Famotidine H E B ANDA Current 37808-042 Acid Controller Famotidine H E B ANDA Current 41163-001 equaline heartburn prevention Famotidine Supervalu Inc ANDA Current 41163-001 equaline heartburn prevention Famotidine Supervalu Inc ANDA Current 41163-001 equaline heartburn prevention Famotidine Supervalu Inc ANDA Current 41163-001 equaline heartburn prevention Famotidine Supervalu Inc ANDA Current 41190-194 ShopRite Acid Reducer Famotidine Wakefern Food Corporation ANDA Current 41250-194 Acid Reducer Famotidine Meijer Distribution Inc ANDA Current 41250-194 Acid Reducer Famotidine Meijer Distribution Inc ANDA Current 41250-194 Acid Reducer Famotidine Meijer Distribution Inc ANDA Current 41250-712 heartburn relief famotidine Meijer Distribution Inc ANDA Current 41250-712 heartburn relief famotidine Meijer Distribution Inc ANDA Current 41250-712 heartburn relief famotidine Meijer Distribution Inc ANDA Current 41250-712 heartburn relief famotidine Meijer Distribution Inc ANDA Current 41520-707 CareOne Acid Relief Famotidine American Sales Company ANDA Current 41520-707 CareOne Acid Relief Famotidine American Sales Company ANDA Current 41520-707 CareOne Acid Relief Famotidine American Sales Company ANDA Current 41520-707 CareOne Acid Relief Famotidine American Sales Company ANDA Current 48433-325 Famotidine Famotidine Safecor Health, LLC ANDA Current 49035-650 Equate Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49035-650 Equate Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49035-650 Equate Famotidine Famotidine Wal-Mart Stores Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31226 ORIG 2006-09-27