Application 077355

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	TABLET, CHEWABLE;ORAL	800MG;10MG;165MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL			2008-02-06

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`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 1 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COMPLETE ACID REDUCER	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	b023cd92-eabb-474b-9b5a-4b46cf48256b	2026-09-08	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
DUAL ACTION COMPLETE	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Amazon.com Services LLC	4e8a936c-b876-4923-ad9e-d23537b5d7cf	2026-07-28	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
COMPLETE ACID REDUCER	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	962ced24-0fb3-4aba-b32e-2e6fa1c1c5d7	2026-07-22	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Good Neighbor Pharmacy Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Amerisource Bergen	b7453c0e-b452-409b-a324-83fdd105bfd0	2026-06-02	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Meijer Distribution Inc	50fe57e1-6678-4697-9b35-4673db67d4fb	2026-06-01	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
COMPLETE ACID REDUCER	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	6ccc03bd-3f36-452a-8945-b3d71cce8241	2026-04-08	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
GOOD SENSE DUAL ACTION COMPLETE	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	L. Perrigo Company	b5a36da3-7316-493c-b50f-fc5393d858c0	2026-03-24	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
ACID REDUCER COMPLETE	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Walgreen Company	b94b16d3-b52f-4d70-bbb0-d9fb074c891c	2026-03-19	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
complete dual action	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	HyVee Inc	237efe92-b302-4e11-93fe-7b0f727a00aa	2026-03-12	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Walgreen Company	6f1dcfda-c12a-4c3b-80a2-c9e15517c88f	2026-03-03	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355 ndc (product): 0363-0713
Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Meijer Distribution Inc	6e8ed233-9ffb-46f7-9632-d5bc3d3a558b	2026-01-20	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
equaline complete dual action	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	United Natural Foods, Inc. dba UNFI	c32cb5be-e1f8-4510-8685-5e03a7d4224c	2026-01-13	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355 ndc (product): 41163-321
Good Sense Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	L. Perrigo Company	b7154648-8c8c-4ce6-88b7-5442a16143c5	2025-11-14	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355 ndc (product): 0113-0032
acid reducer complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Safeway	4f0a178c-d0ed-4bbc-a8ce-fda3789d25f0	2025-10-14	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Up and Up Dual Action Acid Reducer and Antacid	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Target Corporation	2f020677-77a0-4e13-9397-e9deeda63293	2025-09-10	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
topcare dual action complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Topco Associates LLC	2c5a1694-d6e9-4679-b421-61eaad5403a4	2025-09-04	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355 ndc (product): 36800-082
CareOne Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	American Sales Company	5d4bea42-25d5-4943-b5ed-471eccd36bf8	2025-08-29	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
CareOne Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	American Sales Company	19045840-2d25-43af-8c92-f36c8b903b28	2025-08-28	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
ACID REDUCER COMPLETE	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Safeway	484ad323-82cf-4157-bacb-236af8210c87	2025-08-27	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
dual action complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Publix Super Markets Inc	913073fe-22ce-40a3-ad22-bf3027c21e99	2025-08-14	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355

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 3 · 179 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0032	Good Sense Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	L. Perrigo Company	ANDA	Current
0113-0032	Good Sense Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	L Perrigo Company	ANDA	Current
0113-0032	Good Sense Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	L Perrigo Company	ANDA	Current
0113-0032	Good Sense Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	L. Perrigo Company	ANDA	Current
0113-0032	Good Sense Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	L. Perrigo Company	ANDA	Current
0113-6023	injoy heartburn relief	famotidine, calcium carbonate and magnesium hydroxide	L. Perrigo Company	ANDA	Current
0113-7321	basic care dual action complete	famotidine, calcium carbonate and magnesium hydroxide	L. Perrigo Company	ANDA	Current
0113-7321	basic care dual action complete	famotidine, calcium carbonate and magnesium hydroxide	L. Perrigo Company	ANDA	Current
0363-0321	Acid Controller Complete	famotidine, calcium carbonate and magnesium hydroxide	Walgreen Company	ANDA	Current
0363-0321	Acid Controller Complete	famotidine, calcium carbonate and magnesium hydroxide	Walgreen Company	ANDA	Current
0363-0511	Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Walgreen Company	ANDA	Current
0363-0511	Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Walgreen Company	ANDA	Current
0363-0511	Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Walgreen Company	ANDA	Current
0363-0511	Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Walgreen Company	ANDA	Current
0363-0713	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Walgreen Company	ANDA	Current
0363-0713	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Walgreen Company	ANDA	Current
0363-0713	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Walgreen Company	ANDA	Current
0363-0713	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Walgreen Company	ANDA	Current
0597-0315	DUO Fusion	Famotidine, Calcium carbonate, Magnesium hydroxide	Boehringer Ingelheim Pharmaceuticals, Inc.	ANDA	Current
0597-0320	DUO Fusion	Famotidine, Calcium carbonate, Magnesium hydroxide	Boehringer Ingelheim Pharmaceuticals, Inc.	ANDA	Current
11673-007	up and up famotidine complete	famotidine, calcium carbonate and magnesium hydroxide	Target Corporation	ANDA	Current
11673-007	up and up famotidine complete	famotidine, calcium carbonate and magnesium hydroxide	Target Corporation	ANDA	Current
11673-007	up and up famotidine complete	famotidine, calcium carbonate and magnesium hydroxide	Target Corporation	ANDA	Current
11673-007	up and up famotidine complete	famotidine, calcium carbonate and magnesium hydroxide	Target Corporation	ANDA	Current
11673-010	up and up famotidine complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Target Corporation	ANDA	Current
11673-010	up and up famotidine complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Target Corporation	ANDA	Current
11673-010	up and up famotidine complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Target Corporation	ANDA	Current
11673-010	up and up famotidine complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Target Corporation	ANDA	Current
11673-010	up and up famotidine complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Target Corporation	ANDA	Current
11822-0223	acid reducer plus antacid	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Rite Aid Corporation	ANDA	Current
11822-0223	acid reducer plus antacid	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Rite Aid Corporation	ANDA	Current
11822-0500	Acid Reducer Plus Antacid	famotidine, calcium carbonate and magnesium hydroxide	Rite Aid Corporation	ANDA	Current
11822-0500	Acid Reducer Plus Antacid	famotidine, calcium carbonate and magnesium hydroxide	Rite Aid Corporation	ANDA	Current
11822-0500	Acid Reducer Plus Antacid	famotidine, calcium carbonate and magnesium hydroxide	Rite Aid Corporation	ANDA	Current
11822-0500	Acid Reducer Plus Antacid	famotidine, calcium carbonate and magnesium hydroxide	Rite Aid Corporation	ANDA	Current
21130-087	Signature Care Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Safeway	ANDA	Current
21130-087	Signature Care Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Safeway	ANDA	Current
21130-087	Signature Care Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Safeway	ANDA	Current
21130-087	Signature Care Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Safeway	ANDA	Current
21130-546	signature care acid reducer complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Safeway	ANDA	Current
21130-546	signature care acid reducer complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Safeway	ANDA	Current
24385-201	good neighbor pharmacy complete	famotidine, calcium carbonate and magnesium hydroxide	Amerisource Bergen	ANDA	Current
30142-040	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	Kroger Company	ANDA	Current
30142-040	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	Kroger Company	ANDA	Current
30142-040	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	Kroger Company	ANDA	Current
30142-040	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	Kroger Company	ANDA	Current
30142-040	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	Kroger Company	ANDA	Current
30142-213	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Kroger Company	ANDA	Current
30142-213	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Kroger Company	ANDA	Current
30142-213	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Kroger Company	ANDA	Current
30142-213	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Kroger Company	ANDA	Current
36800-082	topcare dual action complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Topco Associates LLC	ANDA	Current
36800-082	topcare dual action complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Topco Associates LLC	ANDA	Current
36800-082	topcare dual action complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Topco Associates LLC	ANDA	Current
36800-082	topcare dual action complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Topco Associates LLC	ANDA	Current
36800-616	topcare dual action complete	famotidine, calcium carbonate and magnesium hydroxide	Topco Associates LLC	ANDA	Current
36800-616	topcare dual action complete	famotidine, calcium carbonate and magnesium hydroxide	Topco Associates LLC	ANDA	Current
36800-616	topcare dual action complete	famotidine, calcium carbonate and magnesium hydroxide	Topco Associates LLC	ANDA	Current
36800-616	topcare dual action complete	famotidine, calcium carbonate and magnesium hydroxide	Topco Associates LLC	ANDA	Current
37012-009	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Shopko Stores Operating Co., LLC	ANDA	Current
37012-009	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Shopko Stores Operating Co., LLC	ANDA	Current
37012-009	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Shopko Stores Operating Co., LLC	ANDA	Current
37012-009	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Shopko Stores Operating Co., LLC	ANDA	Current
37012-103	Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Shopko Stores Operating Co., LLC	ANDA	Current
37012-103	Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Shopko Stores Operating Co., LLC	ANDA	Current
37012-103	Acid Reducer Complete	famotidine, calcium carbonate and magnesium hydroxide	Shopko Stores Operating Co., LLC	ANDA	Current
37205-680	leader acid reducer complete	famotidine, calcium carbonate and magnesium hydroxide	Cardinal Health	ANDA	Current
37205-681	leader acid reducer complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	Cardinal Health	ANDA	Current
37808-121	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	H E B	ANDA	Current
37808-121	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	H E B	ANDA	Current
37808-121	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	H E B	ANDA	Current
37808-121	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	H E B	ANDA	Current
37808-121	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide	H E B	ANDA	Current
37808-503	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	H E B	ANDA	Current
37808-503	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	H E B	ANDA	Current
37808-503	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	H E B	ANDA	Current
37808-503	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	H E B	ANDA	Current
37808-503	Dual Action Complete	famotidine, calcium carbonate and magnesium hydroxide	H E B	ANDA	Current
41163-321	equaline complete	famotidine, calcium carbonate and magnesium hydroxide	Supervalu Inc	ANDA	Current
41163-321	equaline complete	famotidine, calcium carbonate and magnesium hydroxide	Supervalu Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31227	ORIG	2008-03-20