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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050802
Company: BAUSCH

Products on NDA 050802

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIANA	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	AB1	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050802

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2006	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050802lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050802s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050802_ziana_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2016	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
03/23/2016	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/02/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/20/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/04/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/02/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050802

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050802lbl.pdf

Therapeutic Equivalents for NDA 050802

ZIANA

GEL;TOPICAL; 1.2%;0.025%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAMYCIN PHOSPHATE AND TRETINOIN	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	No	AB1	202564	ACTAVIS MID ATLANTIC
ZIANA	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	Yes	AB1	050802	BAUSCH

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