Application 075704

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE	FAMOTIDINE	TABLET;ORAL	20MG	No	No
002	FAMOTIDINE	FAMOTIDINE	TABLET;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075704-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2001-04-16
A075704-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2001-04-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075704-001	AB
A075704-002	AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL		2001-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075704-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075704-002	FAMOTIDINE	40MG	TABLET / ORAL		2001-04-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075704-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075704-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075704-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075704-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075704-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075704-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075704-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075704-002	AB	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A075704-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075704-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075704-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075704-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075704-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075704-002	AB	1	`a50c72e98297…`

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 12 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FAMOTIDINE	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	fd271deb-c748-bf26-e053-6294a90a11aa	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	60cd0973-f74e-2b70-e053-2a91aa0a4361	2024-06-06	Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	0abfc8e6-7fdf-4828-89f4-2202002f8489	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	75a334ee-48b9-47e7-8225-6e595bed8a74	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Pepcid	FAMOTIDINE	Bausch Health US LLC	a06502d9-7903-4f37-833e-e5763d502def	2024-06-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Rising Pharma Holdings, Inc.	15b87f7f-1abf-4d8a-bdbe-03bea0021a68	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	VKT Pharma Private Limited	1c2cfb3c-eaa0-403f-9589-d706afc06f51	2024-05-22	Warnings	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Maximum Strength Acid Reducer	FAMOTIDINE	TARGET CORPORATION	07a924f1-14cc-4e7d-e063-6394a90ac7f3	2024-05-13	Warnings	Name fallback generic name: FAMOTIDINE
Zantac 360	FAMOTIDINE	Navajo Manufacturing Company Inc.	e328c59c-baed-0e4e-e053-2995a90ab85c	2024-04-15	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Asclemed USA, Inc.	69bd5340-298b-46ca-83c7-0b5ef233f9c5	2024-04-12	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Hikma Pharmaceuticals USA Inc.	1fdf16e5-145d-4c19-a318-fc6c10794b50	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
famotidine	FAMOTIDINE	CHAIN DRUG MARKETING ASSOCIATION, INC.	6daf1ebe-b0a2-4413-bf25-3de6eb64b0c6	2024-03-27	Warnings	Name fallback brand name: famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Direct_Rx	138d9ed1-2f8f-d19d-e063-6394a90a695d	2024-03-13	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	13168d9e-0697-e5fb-e063-6294a90a69ba	2024-03-07	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Maximum Strength Acid Reducer	FAMOTIDINE	TIME CAP LABORATORIES,INC	fe25e1e2-7158-6fe0-e053-6394a90a3bb1	2024-03-06	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	DR. REDDY'S LABORATORIES INC	88ac92eb-5684-46c8-8cd2-3d4aefee26cf	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Amneal Pharmaceuticals NY LLC	443e8ea6-7d51-4db7-8f0b-7a854d45bf23	2024-02-13	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	VKT Pharma Private Limited	4e5db906-992f-476b-9d97-63a4c582bbdc	2024-01-25	Warnings	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Lifestar Pharma LLC	044a510f-33df-4484-8f07-d821f52b9376	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Acid Reducer	FAMOTIDINE	Allegiant Health	adc2721d-2ca7-4a47-bae1-be298fa1c155	2024-01-16	Warnings	Name fallback 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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3020	Famotidine	famotidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3020	Famotidine	famotidine	Mylan Pharmaceuticals Inc	ANDA	Current
0378-3040	Famotidine	famotidine	Mylan Pharmaceuticals Inc	ANDA	Current
51079-966	Famotidine	famotidine	Mylan Institutional Inc.	ANDA	Current
51079-966	Famotidine	famotidine	Mylan Institutional Inc.	ANDA	Current
55154-5464	Famotidine	famotidine	Cardinal Health	ANDA	Current
67296-0183	Famotidine	Famotidine	RedPharm Drug, Inc.	ANDA	Current
67296-0183	Famotidine	Famotidine	RedPharm Drug, Inc.	ANDA	Current
70518-1089	Famotidine	famotidine	REMEDYREPACK INC.	ANDA	Current
70518-1089	Famotidine	famotidine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30993	ORIG	2004-06-04
30992	ORIG	2001-04-16