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 10 of 15 · 284 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Proficient Rx LP	c7327748-835b-44df-848f-8c620d327ce6	2025-02-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	NCS HealthCare of KY, LLC dba Vangard Labs	59b17677-d805-4d9e-9c64-96385ae47bff	2025-01-27	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	direct rx	b1b82d2a-cdb5-3e22-e053-2995a90a917d	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	direct rx	c3de241e-6217-d6e0-e053-2a95a90a35c5	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	AvPAK	dfdca61d-8824-6230-e053-2995a90a209d	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Advanced Rx Pharmacy of Tennessee, LLC	fa18ed52-f038-02dd-e053-6394a90ac946	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Quality Care Products, LLC	3549386a-533d-4e44-8097-f6bc51ee494a	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Sagent Pharmaceuticals	2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c958	2024-12-06	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Geri-Care Pharmaceutical Corp	288a8f87-e84a-a77a-e063-6294a90a86db	2024-12-05	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	GERI-CARE PHARMACEUTICAL CORP	287601b0-04ba-9611-e063-6394a90a9180	2024-12-04	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Zydus Lifesciences Limited	8c17f9e3-9827-4bf9-85ca-72e08a8518ca	2024-11-30		Name fallback generic name: FAMOTIDINE
PEPCID AC Maximum Strength	FAMOTIDINE	Kenvue Brands LLC	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	2024-11-11	Warnings	Name fallback generic name: FAMOTIDINE
Maximum Strength PEPCID AC Icy Cool Mint	FAMOTIDINE	Kenvue Brands LLC	0f343092-4fc7-1fff-e063-6294a90aba6e	2024-11-11	Warnings	Name fallback generic name: FAMOTIDINE
dg health heartburn prevention	FAMOTIDINE	Dolgencorp Inc	679cdecb-9e25-4f43-b4f4-7f5f3fbf2296	2024-11-11	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Upsher-Smith Laboratories, LLC	d528fadf-316f-4fea-9bec-070c01f80d64	2024-11-08	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Alembic Pharmaceuticals Limited	7c0f3fa5-0a44-4a98-bc43-8bff8e95c462	2024-10-31	Adverse reactions	Name fallback generic name: FAMOTIDINE
Acid Reducer	FAMOTIDINE	Allegiant Health	5c6c6665-cb0a-41d1-af28-85b4f061bd1b	2024-10-30	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	American Health Packaging	3a583080-6771-4246-a221-2491e9e5d8af	2024-09-24	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Golden State Medical Supply, Inc.	f67bcbc7-952c-61c0-e053-2a95a90a6fa6	2024-09-20	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	67a6e7f3-04d6-426c-b952-7677a84ace4d	2024-09-06	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

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