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 3 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	db3af7cc-efc6-4934-acff-8bb2d31fe829	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
good sense acid reducer	FAMOTIDINE	L. Perrigo Company	cc77f6ff-a534-4731-b971-491280840899	2026-05-18	Warnings	Name fallback generic name: FAMOTIDINE
Good Sense Acid Reducer	FAMOTIDINE	L. Perrigo Company	39cb0f15-d177-46eb-a549-7acb885fbf07	2026-05-11	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Cardinal Health 107, LLC	5d515c2a-dac9-42d8-aede-66d28a427dbc	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	ST. MARY'S MEDICAL PARK PHARMACY	febe39b1-9212-a281-e053-6394a90a1a9f	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Cardinal Health 107, LLC	cdd5dfb7-4efb-4235-8023-5ce145c09038	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	REMEDYREPACK INC.	8dbf43e0-856f-443b-b8a4-c69e006878ea	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Acid Controller	FAMOTIDINE	Walgreen Company	42392cb1-7958-4a2f-8622-f00f02afd961	2026-04-24	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Preferred Pharmaceuticals Inc.	b445a613-eaa8-45e8-be1f-5848bfd1dd36	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals, Inc.	b1edf3c5-e42c-471b-8771-6c93094822de	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Preferred Pharmaceuticals Inc.	dbf94314-3a34-4f03-80b1-296559b7d6a5	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
acid controller	FAMOTIDINE	CVS Pharmacy	1531aa51-02e9-45ed-99aa-53b21732dd2e	2026-04-06	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	3ab235f4-da59-4a92-ad6b-c76cf3ecd985	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Medical Purchasing Solutions, LLC	4e803491-8030-50d0-e063-6294a90a5c8d	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	545d5c1f-ec1c-4135-965f-333ad888d96f	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	fd5d15b9-b1b5-48ef-ba41-8a43a7642e94	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
acid reducer original strength	FAMOTIDINE	HyVee Inc	a0f2683f-59ad-4f65-a108-696430d577ab	2026-03-16	Warnings	Name fallback generic name: FAMOTIDINE
ACID REDUCER	FAMOTIDINE	Publix Super Markets Inc	3455be3c-696e-402a-a5df-830544fa525a	2026-03-11	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Legacy Pharmaceutical Packaging, LLC	cc88fbdc-546e-332f-e053-2995a90a8ca7	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Acid Controller Original Strength	FAMOTIDINE	Walgreen Company	98c6ddc9-8103-40b3-a145-ffbe3374ab6c	2026-03-03	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