Home Applications 075704 Application 075704
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG No No 002 FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075704-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 A075704-002 FAMOTIDINE FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 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 A075704-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075704-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075704-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075704-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075704-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075704-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075704-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075704-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075704-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075704-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075704-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 74a2ff9319b5…
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 8 of 15 · 289 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Famotidine FAMOTIDINE Aurohealth LLC 6d0d8839-0680-45f6-96db-2d8edc9d4682 2025-04-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Wal-Mart Stores, Inc. 43fb44ea-07a1-4df9-8b4a-b2249757208e 2025-04-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Amerisource Bergen d8df03ab-7c5c-4c8b-a3fb-6c6081e081e7 2025-04-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE WALGREEN CO. 2766ffe7-2f1c-48c8-8f67-0a2819dcc3be 2025-04-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE WALGREEN CO. d0f74e78-7afb-49c2-e053-2a95a90a31dc 2025-04-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE Novadoz Pharmaceuticals LLC 21953598-e7ec-45c2-8fca-05550a1ddf38 2025-04-10 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE acid reducer FAMOTIDINE CVS Pharmacy 373f5e28-e9e2-4af7-8a27-29b5d8f28b50 2025-04-07 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Westminster Pharmaceuticals, LLC c0e15f57-ab20-4030-b1d1-6aff33be7d76 2025-04-07 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE LEADER/ CARDINAL HEALTH 110, INC. cdd509c4-331b-4aee-935c-dfc44d5943ed 2025-04-05 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE WALGREEN CO. e9ded705-85c7-1380-e053-2995a90a68ec 2025-04-05 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Bi-Mart 9974aa5e-e03f-4459-934a-ece27a830746 2025-04-01 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE Bryant Ranch Prepack a24e8f45-6ace-4a81-8005-c23a55dadd9a 2025-03-31 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE Famotidine FAMOTIDINE Best Choice fadb9d53-4cc6-83d6-e053-6394a90aa2e3 2025-03-28 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Amerisource Bergen a5d88925-efca-4240-9eb5-6a9d0ac7a67e 2025-03-28 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Better Living Brands LLC f6f07e25-2b31-b0c4-e053-6294a90a8ffb 2025-03-28 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE HARRIS TEETER, LLC e49e087c-ee20-3174-e053-2995a90a1d09 2025-03-28 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-3020 Famotidine famotidine Mylan Pharmaceuticals Inc. ANDA Current 0378-3020 Famotidine famotidine Mylan Pharmaceuticals Inc ANDA Current 0378-3040 Famotidine famotidine Mylan Pharmaceuticals Inc ANDA Current 51079-966 Famotidine famotidine Mylan Institutional Inc. ANDA Current 51079-966 Famotidine famotidine Mylan Institutional Inc. ANDA Current 55154-5464 Famotidine famotidine Cardinal Health ANDA Current 67296-0183 Famotidine Famotidine RedPharm Drug, Inc. ANDA Current 67296-0183 Famotidine Famotidine RedPharm Drug, Inc. ANDA Current 70518-1089 Famotidine famotidine REMEDYREPACK INC. ANDA Current 70518-1089 Famotidine famotidine REMEDYREPACK INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30993 ORIG 2004-06-04 30992 ORIG 2001-04-16