Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020743
Company: BAUSCH

Products on NDA 020743

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORITATE	METRONIDAZOLE	1%	CREAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020743

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020743_noritate_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/04/2004	SUPPL-6	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20743scp006ltr.pdf
04/04/2003	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020743s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20743slr002ltr.pdf

Labels for NDA 020743

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2003	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020743s002lbl.pdf