An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.html

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

Top