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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020958
Company: J AND J CONSUMER INC

Products on NDA 020958

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEPCID COMPLETE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020958

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2000	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20958lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20958ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-958_Pepcid.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2019	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020958Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020958Orig1s029ltr.pdf
04/09/2019	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020958Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020958Orig1s028ltr.pdf
12/21/2018	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020958Orig1s027Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020958Orig1s027Ltr.pdf
06/08/2016	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020958Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020958Orig1s025ltr.pdf
07/14/2015	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
03/20/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
12/07/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/30/2013	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020958Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020958Orig1s018ltr.pdf
04/01/2013	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/18/2008	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020958s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020958Orig1s015.pdf
06/09/2006	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020958s013LTR.pdf
07/18/2005	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020958s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020958s012ltr.pdf
10/27/2004	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf
11/05/2003	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20958slr007ltr.pdf
11/22/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/06/2001	SUPPL-2	Manufacturing (CMC)-Formulation	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001//20958s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020958_S002_PEPCIDTOC.cfm
09/24/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020958

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2019	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020958Orig1s029lbl.pdf
04/09/2019	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020958Orig1s028lbl.pdf
12/21/2018	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020958Orig1s027Lbl.pdf
06/08/2016	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020958Orig1s025lbl.pdf
07/30/2013	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020958Orig1s018lbl.pdf
07/18/2005	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020958s012lbl.pdf
11/06/2001	SUPPL-2	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001//20958s2lbl.pdf
10/16/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20958lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

PEPCID COMPLETE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, CHEWABLE;ORAL; 800MG;10MG;165MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE;ORAL	Over-the-counter	No	077355	PERRIGO R AND D
PEPCID COMPLETE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE;ORAL	Over-the-counter	Yes	020958	J AND J CONSUMER INC

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