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 6 of 15 · 289 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Famotidine FAMOTIDINE Preferred Pharmaceuticals Inc. 5ed77259-5dd9-4634-a073-346693488c4f 2025-09-23 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Preferred Pharmaceuticals Inc. 6edbd842-cf86-48a5-bc22-967620a2b5cb 2025-09-05 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE basic care heartburn prevention FAMOTIDINE Amazon.com Services LLC 8d57f6db-a9f0-4416-9f49-17ce3571b0aa 2025-09-04 Warnings Name fallback generic name: FAMOTIDINE careone acid relief FAMOTIDINE Retail Business Services, LLC 2f0f90cf-8f9a-4102-aab6-941aa0d35e4f 2025-08-26 Warnings Name fallback generic name: FAMOTIDINE maximum strength FAMOTIDINE Publix Super Markets Inc f692ed61-d09a-484e-bf07-8afcedfb3208 2025-08-21 Warnings Name fallback generic name: FAMOTIDINE Leader Acid Reducer FAMOTIDINE Cardinal Health 110, LLC. dba Leader 321b83f9-4bbf-494a-9279-80b0742049b6 2025-08-21 Warnings Name fallback generic name: FAMOTIDINE foster and thrive acid reducer FAMOTIDINE Strategic Sourcing Services LLC 0c480ba4-b07e-4109-a9a9-5480b4a39a1d 2025-08-21 Warnings Name fallback generic name: FAMOTIDINE members mark acid pep FAMOTIDINE Sam's West Inc f9f4a91c-60a2-4893-88e6-639d24237375 2025-08-21 Warnings Name fallback generic name: FAMOTIDINE TopCare Acid Reducer FAMOTIDINE Topco Associates LLC c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe 2025-08-15 Warnings Name fallback generic name: FAMOTIDINE Rugby Famotidine FAMOTIDINE Rugby Laboratories cdb6caa5-5be6-4597-a930-b8c816ac3040 2025-08-13 Warnings Name fallback generic name: FAMOTIDINE ACID CONTROLLER FAMOTIDINE Safeway 9ddfb9fd-1b84-4e9a-90b5-6a3362d345dd 2025-08-13 Warnings Name fallback generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE Ascend Laboratories, LLC be69d9f9-f4ad-4cfe-bab2-e07186b25c1e 2025-08-07 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE acid controller FAMOTIDINE Safeway f3d08f06-a676-43b0-8f77-611f0af737a7 2025-08-07 Warnings Name fallback generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE Micro Labs Limited 1756ab7d-05c4-4726-8f72-4e8363440968 2025-07-29 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE Famotidine FAMOTIDINE Chain Drug Marketing Association INC 7fbc5e10-30c6-7f8d-1040-d48a80fe4d79 2025-07-22 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Acid Reducer Original Strength FAMOTIDINE Dr.Reddys Laboratories Inc. ca039876-f7e5-3e60-da5a-a1f40637a417 2025-07-17 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Albertsons Companies 27314f55-5e31-703c-b98c-ec89bf308472 2025-07-17 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Family Dollar Stores, Inc. 0f81e8ac-ddad-13d6-e883-6a5310e058de 2025-07-17 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Discount Drug Mart, Inc c5d81352-c45b-3ea1-9974-8a096bd05009 2025-07-17 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Chain Drug Consortium, LLC 937f7bce-955b-9418-5aed-2e84aee50de3 2025-07-17 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