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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205223
Company: CHEMO RESEARCH SL

Summary Review

Products on NDA 205223

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUVESSA	METRONIDAZOLE	1.3%	GEL;VAGINAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205223

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205223Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205223Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205223Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2022	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205223s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205223Orig1s006ltr.pdf
12/06/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205223s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205223Orig1s005ltr.pdf
08/03/2018	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205223s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205223Orig1s002ltr.pdf
12/14/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for NDA 205223

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205223s006lbl.pdf
02/25/2022	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205223s006lbl.pdf
12/06/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205223s005lbl.pdf
08/03/2018	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205223s002lbl.pdf
03/24/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf

Therapeutic Equivalents for NDA 205223

NUVESSA

GEL;VAGINAL; 1.3%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METRONIDAZOLE	METRONIDAZOLE	1.3%	GEL;VAGINAL	Prescription	No	AB	216795	ENCUBE
NUVESSA	METRONIDAZOLE	1.3%	GEL;VAGINAL	Prescription	Yes	AB	205223	CHEMO RESEARCH SL

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