Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050801
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EVOCLIN | CLINDAMYCIN PHOSPHATE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM;TOPICAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/22/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21709lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21709ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050801s000_EvoclinTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/17/2018 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050801s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050801Orig1s018ltr.pdf | |
| 01/20/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/2012 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050801s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050801s015ltr.pdf | |
| 12/21/2010 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050801s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050801s011ltr.pdf | |
| 07/11/2006 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050801s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050801s006LTR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/17/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050801s018lbl.pdf | |
| 01/20/2012 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050801s015lbl.pdf | |
| 12/21/2010 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050801s011lbl.pdf | |
| 07/11/2006 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050801s006lbl.pdf | |
| 10/22/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21709lbl.pdf |