Home Applications 077367 Application 077367
Type ANDA
Sponsor DR REDDYS LABS LTD 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 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A077367-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 A077367-002 FAMOTIDINE FAMOTIDINE 10MG TABLET / ORAL 2001-08-17
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 · 80 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 2026-08-18 06:07:40 2026-07 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077367-002 FAMOTIDINE 10MG TABLET / ORAL 2001-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077367-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 782e0a99824c…
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 · 8 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 37 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43598-824 Acid Reducer Famotidine Dr.Reddys Laboratories Inc. ANDA Current 43598-824 Acid Reducer Famotidine Dr.Reddys Laboratories Inc. ANDA Current 43598-824 Acid Reducer Famotidine Dr.Reddys Laboratories Inc. ANDA Current 43598-824 Acid Reducer Famotidine Dr.Reddys Laboratories Inc. ANDA Current 43598-960 Acid Reducer Famotidine Dr.Reddys Laboratories Inc. ANDA Current 43598-960 Acid Reducer Famotidine Dr.Reddys Laboratories Inc. ANDA Current 43598-960 Acid Reducer Famotidine Dr.Reddys Laboratories Inc. ANDA Current 43598-960 Acid Reducer Famotidine Dr.Reddys Laboratories Inc. ANDA Current 49035-118 Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49035-118 Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49035-118 Famotidine Famotidine Wal-Mart Stores Inc ANDA Current 49035-396 Famotidine Famotidine Walmart Stores Inc. ANDA Current 49035-396 Famotidine Famotidine Walmart Stores Inc. ANDA Current 53943-100 Famotidine Famotidine Discount Drug Mart, Inc ANDA Current 53943-100 Famotidine Famotidine Discount Drug Mart, Inc ANDA Current 53943-101 Famotidine Famotidine Discount Drug Mart, Inc ANDA Current 53943-101 Famotidine Famotidine Discount Drug Mart, Inc ANDA Current 55111-118 Famotidine Famotidine Dr.Reddys Laboratories Limited ANDA Current 55111-118 Famotidine Famotidine Dr.Reddys Laboratories Limited ANDA Current 55111-118 Famotidine Famotidine Dr.Reddys Laboratories Limited ANDA Current 55111-118 Famotidine Famotidine Dr.Reddys Laboratories Limited ANDA Current 55111-396 Famotidine Famotidine Dr.Reddys Laboratories Limited ANDA Current 55111-396 Famotidine Famotidine Dr.Reddys Laboratories Limited ANDA Current 55111-396 Famotidine Famotidine Dr.Reddys Laboratories Limited ANDA Current 55111-396 Famotidine Famotidine Dr.Reddys Laboratories Limited ANDA Current 63868-583 Famotidine Famotidine Chain Drug Marketing Association INC ANDA Current 63868-583 Famotidine Famotidine Chain Drug Marketing Association INC ANDA Current 63868-584 Famotidine Famotidine Chain Drug Marketing Association INC ANDA Current 63868-584 Famotidine Famotidine Chain Drug Marketing Association INC ANDA Current 68016-800 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-800 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-801 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-801 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 69842-266 Acid Controller Famotidine CVS Health Corp ANDA Current 69842-266 Acid Controller Famotidine CVS Health Corp ANDA Current 69842-267 Acid Controller Famotidine CVS Health Corp ANDA Current 69842-267 Acid Controller Famotidine CVS Health Corp ANDA Current