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 1 of 2 · 38 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Famotidine FAMOTIDINE Aurohealth LLC 5b161f25-c578-4ff4-a931-ff3a1e681c50 2026-09-04 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 58602-829 Zantac 360 FAMOTIDINE Select Consumer Group LLC 529cef2d-e6cc-3b37-e063-6294a90aff59 2026-06-27 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE CVS Pharmacy, Inc. 7357f67e-0fc6-4555-aa8b-1df09cba9feb 2026-06-24 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 69842-063 Famotidine FAMOTIDINE Family Dollar Stores, LLC 4dc7c2c4-83c7-608d-e063-6294a90a90eb 2026-06-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Zantac 360 Cool Mint FAMOTIDINE Chattem, Inc. 19fe7c6e-243c-4005-a63a-f8cac1ce55c8 2025-09-30 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Zantac 360 FAMOTIDINE Chattem, Inc. 89f60eb1-359b-40e8-ae8b-65aec9cd5b1f 2025-05-09 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Magno-Humphries, Inc. f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9 2025-05-02 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Magno-Humphries, Inc. ed32f72a-e220-440f-a74f-b754a313f004 2025-05-02 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE LEADER/ CARDINAL HEALTH 110, INC. 78b168f1-846d-4e88-a8ee-845c41c9dcbe 2025-04-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 70000-0049 Famotidine FAMOTIDINE Better Living Brands, LLC f6f0230c-44fb-6c36-e053-6394a90ac43e 2025-04-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Fred's, Inc. 81b105a1-01fe-51d7-e053-2991aa0a71bc 2025-04-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE CVS Pharmacy, Inc. c4e35c7e-5c2f-4252-e053-2a95a90a8268 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 69842-924 Famotidine FAMOTIDINE CVS Pharmacy, Inc. 479a1437-a212-49d9-b272-758c0e5b7203 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 69842-087 Famotidine FAMOTIDINE Best Choice fadbd056-6510-f864-e053-6294a90aa67b 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Aurohealth LLC f2b911c7-ce24-4d3d-8fb6-c34980191f40 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Aurohealth LLC 6d0d8839-0680-45f6-96db-2d8edc9d4682 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 58602-859 Famotidine FAMOTIDINE Wal-Mart Stores, Inc. 43fb44ea-07a1-4df9-8b4a-b2249757208e 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Amerisource Bergen d8df03ab-7c5c-4c8b-a3fb-6c6081e081e7 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE WALGREEN CO. 2766ffe7-2f1c-48c8-8f67-0a2819dcc3be 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE WALGREEN CO. d0f74e78-7afb-49c2-e053-2a95a90a31dc 2025-04-22 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 2 of 2 · 156 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58602-829 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-829 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-829 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-829 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-829 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-859 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-859 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-859 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-859 Famotidine Famotidine Aurohealth LLC ANDA Current 58602-859 Famotidine Famotidine Aurohealth LLC ANDA Current 63868-562 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 63868-562 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 63868-562 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 63868-562 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 63868-562 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 63868-563 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 63868-563 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 63868-563 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 63868-563 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 63868-563 Famotidine Famotidine C.D.M.A., Inc. ANDA Current 66715-9758 Zantac 360 Famotidine tablet, film-coated Lil' Drug Store Products, Inc ANDA Current 67751-214 Zantac 360 Famotidine Navajo Manufacturing Company Inc. ANDA Current 68001-494 Famotidine Famotidine BluePoint Laboratories ANDA Current 68001-494 Famotidine Famotidine BluePoint Laboratories ANDA Current 68016-096 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-096 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-096 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-096 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-096 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-096 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-097 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-097 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-097 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-097 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-097 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68016-097 Famotidine Famotidine Chain Drug Consortium, LLC ANDA Current 68196-225 Famotidine Famotidine Sam's West Inc ANDA Current 68196-225 Famotidine Famotidine Sam's West Inc ANDA Current 68196-225 Famotidine Famotidine Sam's West Inc ANDA Current 68196-225 Famotidine Famotidine Sam's West Inc ANDA Current 69256-002 Famotidine Famotidine HARRIS TEETER, LLC ANDA Current 69256-002 Famotidine Famotidine HARRIS TEETER, LLC ANDA Current 69842-063 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-063 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-063 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-063 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-063 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-087 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-087 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-087 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-087 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-087 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-087 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-924 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-924 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-928 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 69842-928 Famotidine Famotidine CVS Pharmacy, Inc. ANDA Current 70000-0048 Famotidine Famotidine Cardinal Health ANDA Current 70000-0048 Famotidine Famotidine Cardinal Health ANDA Current 70000-0048 Famotidine Famotidine Cardinal Health ANDA Current 70000-0048 Famotidine Famotidine Cardinal Health ANDA Current 70000-0048 Famotidine Famotidine Cardinal Health ANDA Current 70000-0049 Famotidine Famotidine Cardinal Health ANDA Current 70000-0049 Famotidine Famotidine Cardinal Health ANDA Current 70000-0049 Famotidine Famotidine Cardinal Health ANDA Current 70000-0049 Famotidine Famotidine Cardinal Health ANDA Current 70000-0049 Famotidine Famotidine Cardinal Health ANDA Current 71205-637 Famotidine Famotidine Proficient Rx LP ANDA Current 71205-637 Famotidine Famotidine Proficient Rx LP ANDA Current 71205-663 Famotidine Famotidine Proficient Rx LP ANDA Current 72036-026 Famotidine Famotidine Harris Teeter ANDA Current 72036-026 Famotidine Famotidine Harris Teeter ANDA Current 72036-026 Famotidine Famotidine Harris Teeter ANDA Current 72036-026 Famotidine Famotidine Harris Teeter ANDA Current 72036-026 Famotidine Famotidine Harris Teeter ANDA Current 72036-026 Famotidine Famotidine Harris Teeter ANDA Current