Home Applications 075684 Application 075684
Type ANDA
Sponsor ATHENEX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FAMOTIDINE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075684-001 FAMOTIDINE FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075684-001 AP
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 · 43 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 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075684-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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.
Documents# Document, Submission type, Date table Document Submission type Date 43019 ORIG 2003-07-30 30987 ORIG 2001-04-16