Home Applications 075786 Application 075786
Type ANDA
Sponsor CELLTRION 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 1 .
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 A075786-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 A075786-002 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 · 82 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 2026-02-19 14:30 UTC 2026-02 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 33261-562 Famotidine Famotidine Aidarex Pharmaceuticals LLC ANDA Current 55648-936 Famotidine Famotidine Wockhardt Limited ANDA Current 55648-937 Famotidine Famotidine Wockhardt Limited ANDA Current 64679-936 Famotidine Famotidine Wockhardt USA LLC. ANDA Current 64679-937 Famotidine Famotidine Wockhardt USA LLC. ANDA Current 68151-0185 Famotidine Famotidine Carilion Materials Management ANDA Current 68788-9549 Famotidine Famotidine Preferred Pharmaceuticals, Inc. ANDA Current 68788-9779 Famotidine Famotidine Preferred Pharmaceuticals, Inc. ANDA Current 72606-509 Famotidine Famotidine CELLTRION USA, INC. ANDA Current 72606-509 Famotidine Famotidine CELLTRION USA, INC. ANDA Current 72606-510 Famotidine Famotidine CELLTRION USA, INC. ANDA Current 72606-510 Famotidine Famotidine CELLTRION USA, INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31017 ORIG 2004-06-04 8788 ORIG 2001-04-16