Home Applications 077352 Application 077352
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 40MG No No 002 FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077352-001 FAMOTIDINE FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 A077352-002 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2005-07-27
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 · 88 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 2026-10-15 13:18:30 2026-09 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077352-001 FAMOTIDINE 40MG TABLET / ORAL 2005-07-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077352-002 FAMOTIDINE 20MG TABLET / ORAL 2005-07-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077352-001 FAMOTIDINE 40MG TABLET / ORAL AB 2005-07-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077352-002 FAMOTIDINE 20MG TABLET / ORAL AB 2005-07-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077352-001 FAMOTIDINE 40MG TABLET / ORAL AB 2005-07-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077352-002 FAMOTIDINE 20MG TABLET / ORAL AB 2005-07-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077352-001 FAMOTIDINE 40MG TABLET / ORAL AB 2005-07-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077352-002 FAMOTIDINE 20MG TABLET / ORAL AB 2005-07-27 4b0b4de00fa7…
Observed Orange Book normalized TE history# 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 7 of 15 · 284 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Famotidine FAMOTIDINE Proficient Rx LP 702dd4fa-4a78-454d-91c5-493894750f7b 2025-07-01 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE acid controller FAMOTIDINE H E B 813d742f-8f3d-4f18-a6c5-03eea946f976 2025-06-23 Warnings Name fallback generic name: FAMOTIDINE TopCare Acid Reducer FAMOTIDINE Topco Associates LLC 88722f84-dac8-4130-93b3-9e0dc1cc5acc 2025-06-13 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE FAMILY DOLLAR 99698eea-6bf1-42e8-9f48-d58fc0437324 2025-06-06 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Dr.Reddys Laboratories Limited 387088a6-8eaa-fc49-8050-a546d0f0fd32 2025-06-03 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Calmicid AC Acid Reducer FAMOTIDINE Melaleuca, Inc. 369ae213-cd23-57ba-e063-6394a90a87a6 2025-06-02 Warnings Name fallback generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE Carnegie Pharmaceuticals LLC 45df5fae-b28a-4b48-95ef-96e4faad883f 2025-05-30 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE Famotidine FAMOTIDINE Precision Dose, Inc. de42b6c4-c44b-4ec1-b505-fc5266452d57 2025-05-27 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Zantac 360 FAMOTIDINE Chattem, Inc. 89f60eb1-359b-40e8-ae8b-65aec9cd5b1f 2025-05-09 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Lannett Company, Inc. 7e0da8be-b001-400e-99d1-37f335b1d7b3 2025-05-02 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Magno-Humphries, Inc. f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9 2025-05-02 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Magno-Humphries, Inc. ed32f72a-e220-440f-a74f-b754a313f004 2025-05-02 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE LEADER/ CARDINAL HEALTH 110, INC. 78b168f1-846d-4e88-a8ee-845c41c9dcbe 2025-04-23 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Bryant Ranch Prepack 11ce2a78-76ce-44df-afe3-57493498e596 2025-04-23 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Better Living Brands, LLC f6f0230c-44fb-6c36-e053-6394a90ac43e 2025-04-23 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Fred's, Inc. 81b105a1-01fe-51d7-e053-2991aa0a71bc 2025-04-23 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE CVS Pharmacy, Inc. c4e35c7e-5c2f-4252-e053-2a95a90a8268 2025-04-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE CVS Pharmacy, Inc. 479a1437-a212-49d9-b272-758c0e5b7203 2025-04-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Best Choice fadbd056-6510-f864-e053-6294a90aa67b 2025-04-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Aurohealth LLC f2b911c7-ce24-4d3d-8fb6-c34980191f40 2025-04-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.