Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006530
Company: MYLAN SPECIALITY LP
Company: MYLAN SPECIALITY LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AVC | SULFANILAMIDE | 15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;VAGINAL | Discontinued | None | Yes | No |
AVC | SULFANILAMIDE | 1.05GM | SUPPOSITORY;VAGINAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
06/05/1965 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/24/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/18/2013 | SUPPL-19 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006530s019lbl.pdf | |
04/19/2002 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/13/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/24/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/27/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
01/27/1987 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
01/27/1987 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/18/2013 | SUPPL-19 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006530s019lbl.pdf |