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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021385
Company: BAUSCH

Products on NDA 021385

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERTACZO	SERTACONAZOLE NITRATE	2%	CREAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/2003	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21385_Ertaczo_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21385ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-385_Ertaczo.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2020	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021385s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021385Orig1s006ltr.pdf
01/22/2014	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021385s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021385Orig1s005ltr.pdf
11/22/2005	SUPPL-3	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021385s003ltr.pdf

Labels for NDA 021385

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2020	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021385s006lbl.pdf
12/17/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021385s006lbl.pdf
01/22/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021385s005lbl.pdf
12/10/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21385_Ertaczo_lbl.pdf

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