Application 075512

Type: ANDA
Sponsor: P AND L

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE	FAMOTIDINE	TABLET;ORAL	10MG	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
A075512-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2001-07-26

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	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075512-001	FAMOTIDINE	10MG	TABLET / ORAL	2001-07-26	`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 11 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Alembic Pharmaceuticals Limited	7c0f3fa5-0a44-4a98-bc43-8bff8e95c462	2024-10-31	Adverse reactions	Name fallback brand name: Famotidine 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 brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Golden State Medical Supply, Inc.	f67bcbc7-952c-61c0-e053-2a95a90a6fa6	2024-09-20	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	67a6e7f3-04d6-426c-b952-7677a84ace4d	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	92a75aa6-3c63-4c98-be8e-dcd03affc10b	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	81f24752-3474-3013-0013-5570c8e7baf7	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	82930f64-4556-491f-96cc-270be9e3589a	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	4adb4864-04ac-4cb1-96c2-6196a30ac640	2024-09-01	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Carlsbad Technology, Inc	a8b5c855-053d-4295-8f57-1a96a6ccaa92	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	72a97532-9a79-4cbf-b9d0-22ce1f21468d	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	077bb160-e616-4863-bdde-989140f99e1c	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	8dc075fe-a3e5-4710-8c19-73558a8c5f09	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	66878006-8913-4c91-8038-901142cf520d	2024-08-21	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Baxter Healthcare Corporation	97c33213-f415-4718-8466-9aa50371af70	2024-08-20	Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals, Inc.	4b820924-24ad-4a2f-e054-00144ff88e88	2024-07-19	Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	b556d1a8-4155-50cf-e053-2995a90a9b14	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Original strength heartburn prevention	FAMOTIDINE	KROGER COMPANY	ea1c2838-acbd-18e0-e053-2a95a90a3522	2024-07-08	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Contract Pharmacal Corp.	273deac8-c2b0-423f-8662-4f16d91df216	2024-07-04	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2748	Famotidine	Famotidine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2748	Famotidine	Famotidine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2748	Famotidine	Famotidine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2748	Famotidine	Famotidine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
63629-7909	Famotidine	Famotidine	Bryant Ranch Prepack	ANDA	Current