Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050793
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDESSE | CLINDAMYCIN PHOSPHATE | EQ 2% BASE | CREAM;VAGINAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
11/30/2004 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/050793ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050793s000_ClinesseTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/03/2023 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050793s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050793Orig1s031ltr.pdf | |
01/18/2017 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/01/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/11/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/22/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/09/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/16/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/15/2012 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050793s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050793s015ltr.pdf | |
12/15/2010 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050793s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050793s014ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/03/2023 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050793s031lbl.pdf | |
02/15/2012 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050793s015lbl.pdf | |
12/15/2010 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050793s014lbl.pdf | |
11/30/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf |