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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050793
Company: PADAGIS US

Products on NDA 050793

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDESSE	CLINDAMYCIN PHOSPHATE	EQ 2% BASE	CREAM;VAGINAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050793

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2004	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/050793ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050793s000_ClinesseTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2023	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050793s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050793Orig1s031ltr.pdf
01/18/2017	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
03/01/2016	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
02/11/2016	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
09/22/2014	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/09/2013	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
01/16/2013	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/15/2012	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050793s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050793s015ltr.pdf
12/15/2010	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050793s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050793s014ltr.pdf

Labels for NDA 050793

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2023	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050793s031lbl.pdf
02/15/2012	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050793s015lbl.pdf
12/15/2010	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050793s014lbl.pdf
11/30/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf

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