Application 076324

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE PRESERVATIVE FREE	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
A076324-001	FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION			2002-11-27

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076324-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2002-11-27	`f41ea6bd6efb…`

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 13 of 15 · 284 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Zydus Pharmaceuticals USA Inc.	b165979b-7ed0-423e-9aeb-2e061df0cd45	2023-10-06	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	ANI Pharmaceuticals, Inc.	8e41e259-b161-4f11-a6f7-14e6b60885b8	2023-10-02	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	NorthStar Rx LLC	04aaf296-f136-29d7-e063-6294a90affe1	2023-09-07	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Ascend Laboratories, LLC	ea50552f-f9b9-467f-a925-62ff027df607	2023-08-25	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Camber Pharmaceuticals, Inc.	8e7f9c85-d165-47c7-8950-b22adcd6cece	2023-08-23	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	74ff64f2-d882-411f-bac8-29dfa4cb4f10	2023-08-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Maximum Strength Acid Controller	FAMOTIDINE	BETTER LIVING BRANDS LLC.	f2c031b4-de86-3a8e-e053-2a95a90a21e0	2023-07-30	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Biocon Pharma Inc.	ea7287a4-75e0-39d2-5b2e-b72b7cb386b9	2023-05-21	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Medical Purchasing Solutions, LLC	bbeffa0a-2bc7-fea4-e053-2a95a90ac511	2023-05-08	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Medical Purchasing Solutions, LLC	b6214fc9-a274-ef45-e053-2a95a90ae43a	2023-05-04	Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	BluePoint Laboratories	befd8d44-c6f7-eca2-e053-2995a90a714b	2023-03-23	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	fe21daca-ac48-4b46-9cb3-9a69af0c6a84	2023-03-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Zydus Pharmaceuticals USA Inc.	a8010e10-68fd-455f-968f-d62a1c3e0ffd	2022-12-02	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Fresenius Kabi USA, LLC	aeb27cea-1ff7-4a6e-93f1-d4c4dac5faa7	2022-11-08	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Fresenius Kabi USA, LLC	5995d726-f3f8-4c2d-af19-1b12e3f769c6	2022-10-20	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
famotidine	FAMOTIDINE	Camber Consumer Care Inc	ebe3ca30-df25-4c56-8935-414a3431b5b9	2022-10-11	Warnings	Name fallback 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 generic name: FAMOTIDINE
famotidine	FAMOTIDINE	Navinta LLC	0f34a3be-7554-4040-b808-5ba8bf064abc	2022-09-17	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	f32d0929-de22-4bec-9e24-bb549cf2679f	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.