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 15 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Aphena Pharma Solutions - Tennessee, LLC	46c6d243-eefc-40ca-8bd4-4c89456f635f	2021-05-18	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	BluePoint Laboratories	8c7ca3cc-ff90-42a7-9218-554cf15348a3	2021-04-13	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Dr.Reddy's Laboratories Limited	06d286ce-14b3-4b66-8b42-ac4a10a0fc90	2020-11-17	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Aphena Pharma Solutions - Tennessee, LLC	b1839d23-20f4-4651-a7d2-8bc3a7583917	2020-07-06	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	1e2003d4-09a3-4cc8-af3d-93d29b9123c0	2020-07-01	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	92048836-e692-4ce1-93f4-88b00acabcde	2019-11-01	Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
heartburn relief original strength	FAMOTIDINE	Proficient Rx LP	5567aaaf-b4f2-4604-b841-c9447e77256c	2019-10-01	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Teva Pharmaceuticals USA, Inc.	4c6f4f9e-f3f5-4ecf-9f40-887e037e8847	2019-01-01	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Lupin Pharmaceuticals,Inc.	a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8	2017-11-21	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