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 1 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 2 of 2 · 158 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49035-650 Equate Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49035-650 Equate Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49348-817 SunMark Acid Reducer Famotidine Strategic Sourcing Services LLC ANDA Current 49348-817 SunMark Acid Reducer Famotidine Strategic Sourcing Services LLC ANDA Current 49348-817 SunMark Acid Reducer Famotidine McKesson ANDA Current 49348-817 SunMark Acid Reducer Famotidine Strategic Sourcing Services LLC ANDA Current 49738-299 Smart Sense Famotidine Famotidine Kmart Corporation ANDA Current 49738-299 Smart Sense Famotidine Famotidine Kmart Corporation ANDA Current 50594-002 sound body acid reducer Famotidine Big Lots Stores, Inc. ANDA Current 50594-002 sound body acid reducer Famotidine Big Lots Stores, Inc. ANDA Current 50594-002 sound body acid reducer Famotidine Big Lots Stores, Inc. ANDA Current 50594-002 sound body acid reducer Famotidine Big Lots Stores, Inc. ANDA Current 50594-002 sound body acid reducer Famotidine Big Lots Stores, Inc. ANDA Current 55316-194 Healthy Accents Famotidine Famotidine DZA Brands LLC ANDA Current 55319-377 Family Wellness Acid Reducer Famotidine Family Dollar Services Inc ANDA Current 55319-377 Family Wellness Acid Reducer Famotidine Family Dollar Services Inc ANDA Current 55319-377 Family Wellness Acid Reducer Famotidine Family Dollar Services Inc ANDA Current 55319-377 Family Wellness Acid Reducer Famotidine Family Dollar Services Inc ANDA Current 55910-194 dg health heartburn prevention Famotidine Dolgencorp Inc ANDA Current 55910-194 dg health heartburn prevention Famotidine Dolgencorp Inc ANDA Current 55910-194 dg health heartburn prevention Famotidine Dolgencorp Inc ANDA Current 55910-194 dg health heartburn prevention Famotidine Dolgencorp Inc ANDA Current 55910-194 dg health heartburn prevention Famotidine Dolgencorp Inc ANDA Current 55910-194 dg health heartburn prevention Famotidine Dolgencorp Inc ANDA Current 55910-194 dg health heartburn prevention Famotidine Dolgencorp Inc ANDA Current 55910-194 dg health heartburn prevention Famotidine Dolgencorp Inc ANDA Current 55910-194 dg health heartburn prevention Famotidine Dolgencorp Inc ANDA Current 55910-665 dg health heartburn prevention famotidine Dolgencorp Inc ANDA Current 55910-814 dg health acid reducer famotidine Dolgencorp Inc ANDA Current 56062-194 maximum strength Famotidine Publix Super Markets Inc ANDA Current 56062-194 maximum strength Famotidine Publix Super Markets Inc ANDA Current 56062-194 maximum strength Famotidine Publix Super Markets Inc ANDA Current 56062-194 maximum strength Famotidine Publix Super Markets Inc ANDA Current 59640-001 Acid Controller famotidine H E B ANDA Current 59640-023 acid reducer famotidine H E B ANDA Current 59779-194 acid controller Famotidine CVS Pharmacy ANDA Current 59779-194 acid controller Famotidine CVS Pharmacy ANDA Current 59779-194 acid controller Famotidine CVS Pharmacy ANDA Current 59779-194 acid controller Famotidine CVS Pharmacy ANDA Current 59779-194 acid controller Famotidine CVS Pharmacy ANDA Current 62011-0143 Health Mart Famotidine Famotidine Strategic Sourcing Services LLC ANDA Current 62011-0143 Health Mart Famotidine Famotidine Strategic Sourcing Services LLC ANDA Current 62011-0143 Health Mart Famotidine Famotidine Strategic Sourcing Services LLC ANDA Current 62011-0143 Health Mart Famotidine Famotidine McKesson ANDA Current 63981-194 kirkland signature acid controller Famotidine Costco Wholesale Company ANDA Current 63981-194 kirkland signature acid controller Famotidine Costco Wholesale Company ANDA Current 63981-194 kirkland signature acid controller Famotidine Costco Wholesale Company ANDA Current 63981-194 kirkland signature acid controller Famotidine Costco Wholesale Company ANDA Current 68196-061 members mark famotidine Famotidine Sam's West Inc ANDA Current 68196-061 members mark famotidine Famotidine Sam's West Inc ANDA Current 68196-061 members mark famotidine Famotidine Sam's West Inc ANDA Current 68196-121 members mark acid pep Famotidine Sam's West Inc ANDA Current 68196-121 members mark acid pep Famotidine Sam's West Inc ANDA Current 68391-300 berkley and jensen famotidine Famotidine BJWC ANDA Current 68391-300 berkley and jensen famotidine Famotidine BJWC ANDA Current 68391-300 berkley and jensen famotidine Famotidine BJWC ANDA Current 68391-300 berkley and jensen famotidine Famotidine BJWC ANDA Current 68391-300 berkley and jensen famotidine Famotidine BJWC ANDA Current 69256-194 harris teeter acid reducer Famotidine Harris Teeter, LLC ANDA Current 69842-659 acid reducer famotidine CVS Pharmacy ANDA Current 70000-0503 leader acid reducer Famotidine Cardinal Health ANDA Current 70000-0503 leader acid reducer Famotidine Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0503 leader acid reducer Famotidine Cardinal Health ANDA Current 70925-194 Humana Pharmacy Acid Reducer Famotidine Humana Pharmacy, Inc. ANDA Current 70925-194 Humana Pharmacy Acid Reducer Famotidine Humana Pharmacy, Inc. ANDA Current 71610-389 Basic Care famotidine Famotidine Aphena Pharma Solutions - Tennessee, LLC ANDA Current 71713-701 heartburn relief Famotidine THIRTY MADISON INC ANDA Current 72288-151 basic care heartburn prevention famotidine Amazon.com Services LLC ANDA Current 72288-194 basic care acid reducer Famotidine Amazon.com Services LLC ANDA Current 72288-194 basic care acid reducer Famotidine Amazon.com Services LLC ANDA Current 72288-194 basic care acid reducer Famotidine Amazon.com Services LLC ANDA Current 72288-329 basic care acid reducer famotidine Amazon.com Services LLC ANDA Current 72476-150 careone acid relief famotidine Retail Business Services, LLC ANDA Current 72476-299 careone acid relief famotidine Retail Business Services, LLC ANDA Current 76162-300 topcare acid reducer famotidine Topco Associates LLC ANDA Current 79903-115 equate famotidine famotidine WALMART INC. ANDA Current 80267-194 betr acid reducer Famotidine Live Betr LLC ANDA Current 80267-194 betr acid reducer Famotidine Live Betr LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31226 ORIG 2006-09-27