Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021758
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANOS | FLUOCINONIDE | 0.1% | CREAM;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 |
---|---|---|---|---|---|---|---|
02/11/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021758lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021758ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021758s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/22/2016 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/18/2016 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/16/2012 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021758s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021758s017ltr.pdf | |
11/10/2011 | SUPPL-16 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021758s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021758s016ltr.pdf | |
12/30/2010 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021758s014ltr.pdf | |
03/08/2010 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021758s012ltr.pdf | |
12/13/2006 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021758s007ltr.pdf | |
03/13/2006 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/23/2005 | SUPPL-2 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021758s002ltr.pdf |
03/02/2006 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s00lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021758s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/16/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021758s017lbl.pdf | |
11/10/2011 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021758s016lbl.pdf | |
12/30/2010 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s014lbl.pdf | |
03/08/2010 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s012lbl.pdf | |
12/13/2006 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s007lbl.pdf | |
03/02/2006 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s00lbl.pdf | |
02/11/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021758lbl.pdf |
VANOS
CREAM;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 200735 | FOUGERA PHARMS INC |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 091282 | GLENMARK PHARMS LTD |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 200734 | TARO |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 208989 | ZYDUS LIFESCIENCES |
VANOS | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB | 021758 | BAUSCH |