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 14 of 15 · 289 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join famotidine FAMOTIDINE Camber Consumer Care Inc ebe3ca30-df25-4c56-8935-414a3431b5b9 2022-10-11 Warnings Name fallback brand name: famotidine generic name: FAMOTIDINE topcare acid reducer FAMOTIDINE Topco Associates LLC 7824fdab-cdd5-457d-9b14-b82b19ea9529 2022-10-03 Warnings Name fallback generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE HF Acquisition Co LLC, DBA HealthFirst 9948991d-9405-c7c8-e053-2995a90a60ca 2022-10-01 Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE famotidine FAMOTIDINE Navinta LLC 0f34a3be-7554-4040-b808-5ba8bf064abc 2022-09-17 Warnings, Adverse reactions Name fallback brand name: famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Proficient Rx LP f32d0929-de22-4bec-9e24-bb549cf2679f 2022-09-01 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Zantac 360 2 per blister 6 blisters FAMOTIDINE JC World Bell Wholesale Co., Inc. fd61a2d6-5c8a-4e7a-8b19-37406b90f778 2022-08-15 Warnings Name fallback generic name: FAMOTIDINE dg health acid reducer FAMOTIDINE Dolgencorp Inc 3ffa405e-bc85-4614-afd0-7a8dfc288dad 2022-07-13 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Proficient Rx LP c84b0ba3-1ba8-4da9-b5b8-186e01cda999 2022-07-01 Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE dg health heartburn prevention FAMOTIDINE Dolgencorp Inc a8383769-ce8b-43eb-b1a6-5d73e7fcf30d 2022-06-07 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Mylan Institutional LLC e3b13e23-122b-4bd4-95cf-b5a14b7afc05 2022-06-01 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Proficient Rx LP 68120de1-fd9a-4f93-b218-d99ed7c5080a 2022-06-01 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Proficient Rx LP 9baf2596-b771-4bae-a03c-d3af6716821d 2022-05-02 Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Proficient Rx LP 787724dc-0b4b-4973-852e-c7d722f637b0 2022-05-01 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Akorn 354a5a02-45cb-4ab0-88ee-6635d5a43b01 2022-03-10 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE Ascent Pharmaceuticals, Inc. b481dd30-7d64-43ec-85d4-2289db62cad7 2022-02-14 Warnings Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE basic care acid reducer FAMOTIDINE Amazon.com Services LLC 94fbcebe-7d75-47c1-9eca-cfa9b952a3d5 2022-01-06 Warnings Name fallback generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE XLCare Pharmaceuticals, Inc. 7b550cf9-221f-4f28-ba99-414ad7d5612f 2021-12-10 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE Famotidine FAMOTIDINE Camber Pharmaceuticals, Inc. 902b5d4b-1707-4312-9f46-ef5ab86b00f0 2021-11-19 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Amneal Pharmaceuticals NY LLC bb602b05-0ce6-4029-bd6e-291076e64efb 2021-08-30 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Fresenius Kabi USA, LLC ce533636-cc9b-45d0-87a6-5390377ff28a 2021-07-15 Warnings, Adverse reactions 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