Home Applications 090283 Application 090283
Type ANDA
Sponsor SUN PHARM INDS 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 A090283-001 FAMOTIDINE FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 A090283-002 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2009-11-17
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 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 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090283-001 FAMOTIDINE 10MG TABLET / ORAL 2009-11-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090283-002 FAMOTIDINE 20MG TABLET / ORAL 2009-11-17 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 7 of 15 · 289 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Famotidine FAMOTIDINE Chain Drug Marketing Association INC 1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a 2025-07-17 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE equate famotidine FAMOTIDINE WALMART INC. f38f8a8f-3292-4fe5-b83f-ffd634196d42 2025-07-16 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Little Pharma, Inc. 33dc93a5-ee03-2e68-e063-6294a90aeee1 2025-07-05 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Proficient Rx LP 702dd4fa-4a78-454d-91c5-493894750f7b 2025-07-01 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE acid controller FAMOTIDINE H E B 813d742f-8f3d-4f18-a6c5-03eea946f976 2025-06-23 Warnings Name fallback generic name: FAMOTIDINE TopCare Acid Reducer FAMOTIDINE Topco Associates LLC 88722f84-dac8-4130-93b3-9e0dc1cc5acc 2025-06-13 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE FAMILY DOLLAR 99698eea-6bf1-42e8-9f48-d58fc0437324 2025-06-06 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Dr.Reddys Laboratories Limited 387088a6-8eaa-fc49-8050-a546d0f0fd32 2025-06-03 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Calmicid AC Acid Reducer FAMOTIDINE Melaleuca, Inc. 369ae213-cd23-57ba-e063-6394a90a87a6 2025-06-02 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Bi-Mart 140440fb-d420-490d-8d7d-4b01c8ed3a83 2025-06-01 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE Carnegie Pharmaceuticals LLC 45df5fae-b28a-4b48-95ef-96e4faad883f 2025-05-30 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE Famotidine FAMOTIDINE Precision Dose, Inc. de42b6c4-c44b-4ec1-b505-fc5266452d57 2025-05-27 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Zantac 360 FAMOTIDINE Chattem, Inc. 89f60eb1-359b-40e8-ae8b-65aec9cd5b1f 2025-05-09 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Lannett Company, Inc. 7e0da8be-b001-400e-99d1-37f335b1d7b3 2025-05-02 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Magno-Humphries, Inc. f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9 2025-05-02 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Magno-Humphries, Inc. ed32f72a-e220-440f-a74f-b754a313f004 2025-05-02 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE LEADER/ CARDINAL HEALTH 110, INC. 78b168f1-846d-4e88-a8ee-845c41c9dcbe 2025-04-23 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Bryant Ranch Prepack 11ce2a78-76ce-44df-afe3-57493498e596 2025-04-23 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Better Living Brands, LLC f6f0230c-44fb-6c36-e053-6394a90ac43e 2025-04-23 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Fred's, Inc. 81b105a1-01fe-51d7-e053-2991aa0a71bc 2025-04-23 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 · 29 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0036 Famotidine Famotidine Walgreen Company ANDA Current 15127-370 Famotidine Famotidine Select Brand ANDA Current 37012-036 Famotidine Famotidine Shopko Stores Operating Co., LLC ANDA Current 37808-036 Famotidine Famotidine HEB ANDA Current 46122-168 Famotidine Famotidine AMERISOURCE BERGEN ANDA Current 46122-168 Famotidine Famotidine AMERISOURCE BERGEN ANDA Current 51660-035 Famotidine Famotidine Ohm Laboratories Inc. ANDA Current 51660-036 Famotidine - Acid Controller Famotidine Ohm Laboratories Inc. ANDA Current 53943-036 Famotidine Famotidine DISCOUNT DRUG MART ANDA Current 53943-037 Famotidine Famotidine DISCOUNT DRUG MART ANDA Current 54473-203 Calmicid AC Loratadine Melaleuca, Inc. ANDA Current 54473-203 Calmicid AC Loratadine Melaleuca, Inc. ANDA Current 55315-035 Famotidine Famotidine Fred's Inc. ANDA Current 57451-5065 Famotidine Famotidine Ipca Laboratories Limited ANDA Current 57451-5066 Famotidine Famotidine Ipca Laboratories Limited ANDA Current 57896-767 Famotidine Famotidine Geri-Care Pharmaceutical Corp ANDA Current 57896-769 Famotidine Famotidine GERI-CARE PHARMACEUTICAL CORP ANDA Current 61715-063 Famotidine famotidine Kinray ANDA Current 61715-064 Famotidine famotidine Kinray ANDA Current 63868-486 Famotidine Famotidine Chain Drug Marketing Association Inc. ANDA Current 63868-714 Famotidine Famotidine Chain Drug Marketing Association Inc. ANDA Current 63941-035 Famotidine Famotidine Valu Merchandisers Company ANDA Current 63941-036 Famotidine Famotidine Valu Merchandisers Company ANDA Current 67091-241 Famotidine - Acid Controller Famotidine WinCo Foods, LLC ANDA Current 67091-242 Famotidine - Acid Controller Famotidine WinCo Foods, LLC ANDA Current 68016-008 Premier Value Famotidine Famotidine Premier Value ANDA Current 68016-008 Premier Value Famotidine Famotidine Premier Value ANDA Current 68016-010 Premier Value Famotidine Famotidine Premier Value ANDA Current 68016-010 Premier Value Famotidine Famotidine Premier Value ANDA Current