Application 020958

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEPCID COMPLETE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	TABLET, CHEWABLE;ORAL	800MG;10MG;165MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50269-016	Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	JC World Bell Wholesale Co., Inc.	NDA	Current
50269-016	Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	JC World Bell Wholesale Co., Inc.	NDA	Current
52904-948	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Select Corporation	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
67751-202	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Navajo Manufacturing Company Inc	NDA	Current
70264-034	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	R J General Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83628	SUPPL	2025-10-02
83626	SUPPL	2025-10-02
81234	SUPPL	2025-02-12
81221	SUPPL	2025-02-12
81114	SUPPL	2025-02-06
81036	SUPPL	2025-02-06
80898	SUPPL	2025-02-04
80897	SUPPL	2025-02-04
59095	SUPPL	2019-06-17
59041	SUPPL	2019-06-12
58339	SUPPL	2019-04-16
58331	SUPPL	2019-04-15
57083	SUPPL	2018-12-31
57051	SUPPL	2018-12-21
35720	SUPPL	2016-06-14
26300	SUPPL	2016-06-14
35719	SUPPL	2013-09-19
26299	SUPPL	2013-08-01
41841	SUPPL	2012-03-27
3850	SUPPL	2008-11-18
41840	SUPPL	2007-06-18
3849	SUPPL	2006-06-12
13815	SUPPL	2005-07-21
3848	SUPPL	2005-07-21
26298	SUPPL	2004-10-29
3847	SUPPL	2003-11-13
41839	ORIG	2003-09-25
13814	SUPPL	2003-04-25
13813	ORIG	2000-10-16
3846	ORIG	2000-10-16

Application 020958

Related Records#

Application Products#

NDC Listings For This Application#

Documents#