Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006882
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHISOHEX | HEXACHLOROPHENE | 3% | EMULSION;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/19/1949 | 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 |
|---|---|---|---|---|---|
| 07/27/2009 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 05/27/2003 | SUPPL-33 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06882slr033ltr.pdf |
| 12/19/2001 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1990 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 07/17/1989 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 12/07/1989 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1988 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1982 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 05/15/1981 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/21/1975 | SUPPL-16 | Labeling |
Label is not available on this site. |