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 4 of 15 · 289 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Famotidine FAMOTIDINE Wal-Mart Stores Inc 8ac94821-aa78-4e57-bc9a-f1f2a0e47b07 2026-03-03 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Proficient Rx LP d60bde93-f512-4071-9e4b-1d8318def3bc 2026-03-01 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE acid controller FAMOTIDINE Walgreen Company c16d9977-39ad-4386-8867-72aab97c99d5 2026-02-28 Warnings Name fallback generic name: FAMOTIDINE berkley and jensen famotidine FAMOTIDINE BJWC 93c857e4-72b3-433e-ae6f-281cd57e3996 2026-02-17 Warnings Name fallback generic name: FAMOTIDINE heartburn relief original strength FAMOTIDINE Major Pharmaceuticals be275c48-18bf-45f6-891d-36d89327813e 2026-02-13 Warnings Name fallback generic name: FAMOTIDINE Pepcid AC Original Strength FAMOTIDINE Kenvue Brands LLC 54f4086f-e443-4e7e-8c7e-94e152e1c256 2026-02-06 Warnings Name fallback generic name: FAMOTIDINE acid reducer FAMOTIDINE H E B 140f0e60-c809-4d86-a750-7649ee2881b5 2026-02-03 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE GLENMARK THERAPEUTICS INC., USA 95f51f27-d367-4cfd-a15f-7856c9e361fb 2026-01-13 Warnings Name fallback brand name: Famotidine generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE Aurobindo Pharma Limited 18066b80-1ec6-4092-80d9-70adb0ecac85 2026-01-09 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE Bryant Ranch Prepack 900b4fd6-9c62-4b64-b4db-760c49ae0a42 2026-01-09 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE Famotidine FAMOTIDINE Alembic Pharmaceuticals Inc. f149ecc1-d66c-42f9-a3f4-2ab6a522942b 2026-01-09 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE acid relief FAMOTIDINE Rite Aid Corporation 45789b7a-e9c7-4813-b07b-f88d9108455d 2026-01-06 Warnings Name fallback generic name: FAMOTIDINE Famotidine FAMOTIDINE Northwind Health Company, LLC f2b6da72-72ea-d81b-e053-2995a90a9526 2026-01-01 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Northwind Health Company, LLC ab1cdbbf-d838-020c-e053-2995a90a0f65 2026-01-01 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE FAMOTIDINE FAMOTIDINE A-S Medication Solutions 74a69baa-a7c5-4e67-8db6-2ec39ab6cfe5 2025-12-30 Warnings, Adverse reactions Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE Famotidine FAMOTIDINE Northwind Health Company, LLC 43454e0f-4e1e-bbc6-e063-6394a90a5ac4 2025-12-29 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Lupin Pharmaceuticals, Inc. 2caaf94b-b382-4573-8614-57815776b659 2025-12-29 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Northwind Health Company, LLC 03503cd5-bd8e-4bff-b90d-1a71c5225b91 2025-12-26 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE Redpharm Drug 37361ccf-e080-d58e-e063-6394a90ab92e 2025-12-24 Warnings, Adverse reactions Name fallback brand name: Famotidine generic name: FAMOTIDINE Famotidine FAMOTIDINE SAFEWAY f18c1195-48a1-69dc-e053-2a95a90a4077 2025-12-18 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