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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020801
Company: KENVUE BRANDS

Products on NDA 020801

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEPCID AC	FAMOTIDINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE;ORAL	Discontinued	None	Yes	No
PEPCID AC	FAMOTIDINE	20MG	TABLET, CHEWABLE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020801

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20801fpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20801ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20801.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2019	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020801Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020801Orig1s020ltr.pdf
03/20/2014	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/11/2013	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/01/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/17/2007	SUPPL-12	Efficacy-New Dosing Regimen	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020801s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020801Orig1s012.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
01/31/2002	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20801s7ltr.pdf
03/29/2001	SUPPL-4	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20801S4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20801S4ltr.pdf
04/26/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/06/2000	SUPPL-2	Labeling		Label is not available on this site.
08/20/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020801

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2019	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020801Orig1s020lbl.pdf
03/29/2001	SUPPL-4	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20801S4lbl.pdf
09/24/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20801fpl.pdf

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

PEPCID AC

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; 20MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
PEPCID AC	FAMOTIDINE	20MG	TABLET, CHEWABLE;ORAL	Over-the-counter	Yes	020801	KENVUE BRANDS

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