Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050802
Company: MEDICIS
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 AB Yes Yes
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.

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

ZIANA

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

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 AB 202564 ACTAVIS MID ATLANTIC
ZIANA CLINDAMYCIN PHOSPHATE; TRETINOIN 1.2%;0.025% GEL;TOPICAL Prescription Yes AB 050802 MEDICIS

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