Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050802
Company: BAUSCH
Company: BAUSCH
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 |
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. |
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03/23/2016 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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07/02/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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08/20/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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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 = 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 |