Home Applications 206531 Application 206531
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FAMOTIDINE FAMOTIDINE TABLET;ORAL 10MG No No 002 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206531-001 FAMOTIDINE FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 A206531-002 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2016-04-26
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 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 74a2ff9319b5…
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 2 of 2 · 38 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Famotidine FAMOTIDINE LEADER/ CARDINAL HEALTH 110, INC. cdd509c4-331b-4aee-935c-dfc44d5943ed 2025-04-05 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE WALGREEN CO. e9ded705-85c7-1380-e053-2995a90a68ec 2025-04-05 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 0363-9607 Famotidine FAMOTIDINE Best Choice fadb9d53-4cc6-83d6-e053-6394a90aa2e3 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Amerisource Bergen a5d88925-efca-4240-9eb5-6a9d0ac7a67e 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Better Living Brands LLC f6f07e25-2b31-b0c4-e053-6294a90a8ffb 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE HARRIS TEETER, LLC e49e087c-ee20-3174-e053-2995a90a1d09 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE CVS Pharmacy, Inc. c4e1ef3d-7391-66f5-e053-2995a90abc00 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Harris Teeter bc548297-7646-4dbf-bfc5-65f2bc629676 2025-03-26 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Aurohealth LLC 27ecf5c1-202a-44cf-94f9-d7fefa027e1e 2025-03-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 58602-828 Famotidine FAMOTIDINE WALGREEN CO. 316e3815-6ae1-47c3-8a75-fd57f8434a6f 2025-03-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 0363-4400 Famotidine FAMOTIDINE Wal-Mart Stores, Inc. 018b02e8-1005-4736-a4fc-962881f52adf 2025-03-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 49035-589 Famotidine FAMOTIDINE Aurohealth LLC 756c7234-6a63-4b1b-be36-2b1ed09e67a0 2025-03-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 58602-705 Zantac 360, Travel BASIX FAMOTIDINE TABLET, FILM-COATED Lil' Drug Store Products, Inc ea38535a-c9db-d03f-e053-2a95a90adf2d 2024-11-19 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Zantac 360 FAMOTIDINE Navajo Manufacturing Company Inc. e328c59c-baed-0e4e-e053-2995a90ab85c 2024-04-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE BluePoint Laboratories befd8d44-c6f7-eca2-e053-2995a90a714b 2023-03-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Zantac 360 2 per blister 6 blisters FAMOTIDINE JC World Bell Wholesale Co., Inc. fd61a2d6-5c8a-4e7a-8b19-37406b90f778 2022-08-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 50269-156 Famotidine FAMOTIDINE Proficient Rx LP 68120de1-fd9a-4f93-b218-d99ed7c5080a 2022-06-01 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Proficient Rx LP 787724dc-0b4b-4973-852e-c7d722f637b0 2022-05-01 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531
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 2 · 156 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-1899 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-4400 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-4400 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-4400 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-4400 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-4400 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-4400 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-4400 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-5300 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-5300 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-5300 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-5300 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-5300 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-5300 Famotidine Famotidine WALGREEN CO. ANDA Current 0363-9607 Famotidine Famotidine WALGREEN CO. ANDA Current 41167-0020 Famotidine Famotidine CHATTEM, INC. ANDA Current 41167-0025 Famotidine Famotidine CHATTEM, INC. ANDA Current 41167-0360 Zantac 360 Famotidine Chattem, Inc. ANDA Current 41167-0360 Zantac 360 Famotidine Chattem, Inc. ANDA Current 41167-0360 Zantac 360 Famotidine Chattem, Inc. ANDA Current 41167-0361 Zantac 360 Famotidine Chattem, Inc. ANDA Current 41167-0361 Zantac 360 Famotidine Chattem, Inc. ANDA Current 41167-0361 Zantac 360 Famotidine Chattem, Inc. ANDA Current 41167-0364 Zantac 360 Cool Mint Famotidine Chattem, Inc. ANDA Current 49035-505 Famotidine Famotidine Wal-Mart Stores, Inc. ANDA Current 49035-505 Famotidine Famotidine Wal-Mart Stores, Inc. ANDA Current 49035-505 Famotidine Famotidine Wal-Mart Inc. ANDA Current 49035-505 Famotidine Famotidine Wal-Mart Inc. ANDA Current 49035-505 Famotidine Famotidine Wal-Mart Inc. ANDA Current 49035-505 Famotidine Famotidine Wal-Mart Stores, Inc. ANDA Current 49035-505 Famotidine Famotidine Wal-Mart Inc. ANDA Current 49035-505 Famotidine Famotidine Wal-Mart Stores, Inc. ANDA Current 49035-589 Famotidine Famotidine Wal-Mart Inc. ANDA Current 49035-589 Famotidine Famotidine Wal-Mart Inc. ANDA Current 49035-589 Famotidine Famotidine Wal-Mart Stores, Inc. ANDA Current 49035-589 Famotidine Famotidine Wal-Mart Inc. ANDA Current 49035-589 Famotidine Famotidine Wal-Mart Stores, Inc. ANDA Current 49035-589 Famotidine Famotidine Wal-Mart Stores, Inc. ANDA Current 50269-155 Zantac 360 1 per blister 6 blisters FAMOTIDINE JC World Bell Wholesale Co., Inc. ANDA Current 50269-156 Zantac 360 2 per blister 6 blisters FAMOTIDINE JC World Bell Wholesale Co., Inc. ANDA Current 52904-926 Zantac 360 famotidine Select Corporation ANDA Current 54257-180 Famotidine Famotidine Magno-Humphries, Inc. ANDA Current 54257-180 Famotidine Famotidine Magno-Humphries, Inc. ANDA Current 54257-180 Famotidine Famotidine Magno-Humphries, Inc. ANDA Current 54257-180 Famotidine Famotidine Magno-Humphries, Inc. ANDA Current 54257-802 Famotidine Famotidine Magno-Humphries, Inc. ANDA Current 54257-802 Famotidine Famotidine Magno-Humphries, Inc. ANDA Current 54257-802 Famotidine Famotidine Magno-Humphries, Inc. ANDA Current 54257-802 Famotidine Famotidine Magno-Humphries, Inc. ANDA Current 55315-435 Famotidine Famotidine Fred's, Inc. ANDA Current 55315-435 Famotidine Famotidine Fred's, Inc. ANDA Current 55315-435 Famotidine Famotidine Fred's, Inc. ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-705 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-706 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-828 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-828 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-828 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-828 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-828 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-829 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-829 Famotidine Famotidine Aurohealth LLC ANDA Current