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 5 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Redpharm Drug	44f3f63d-4522-91e4-e063-6394a90a6d1b	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Ajanta Pharma USA Inc.	a88e7069-230c-4105-ade0-a98968e18671	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Novadoz Pharmaceuticals LLC	74a24590-a0b6-4607-8e67-9fadce53389b	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	AvPAK	85c7d20d-3dec-b918-4c1d-8ca1db214e48	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
famotidine	FAMOTIDINE	Chartwell RX, LLC	70714491-1368-4824-98af-03fda52139a9	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: famotidine generic name: FAMOTIDINE
Heartburn Relief	FAMOTIDINE	Shield Pharmaceuticals Corp	a12ec91d-244f-45c5-8590-d1e4485fe361	2025-10-31	Warnings	Name fallback generic name: FAMOTIDINE
careone acid relief	FAMOTIDINE	Retail Business Services, LLC	8f654234-b25d-47d6-b1f8-f7f353569795	2025-10-30	Warnings	Name fallback generic name: FAMOTIDINE
Acid Controller	FAMOTIDINE	H E B	8aac5a0d-074b-4cf4-ab10-549e1ed09e2f	2025-10-30	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	7cef62ab-1740-4d0f-b6ea-fda783e1c197	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	002875d2-8c30-2d2e-e063-6294a90ae01e	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	66f0bf15-ff35-426a-b40c-0d0da79d0861	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	09ef39a4-c6b3-4395-8211-3f551dc44830	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	5798d282-ce83-49aa-bc33-13203f2b5285	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	2f5ec69d-926c-47a2-be47-8fef2e0ff207	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	c133a9e1-ca48-4ee2-8768-01f44f5dd511	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	3c32f8e2-f54a-422d-9c25-68692ea09001	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	a3b50576-cd40-4f7e-9506-bd0a61988424	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Zantac 360 Cool Mint	FAMOTIDINE	Chattem, Inc.	19fe7c6e-243c-4005-a63a-f8cac1ce55c8	2025-09-30	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	e034546b-28cb-41aa-9441-655cdb966554	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
equaline heartburn prevention	FAMOTIDINE	United Natural Foods, Inc. dba UNFI	f40f1dcf-249a-4ccb-bdfc-acff49dd4a15	2025-09-25	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