Drugs@FDA: FDA-Approved Drugs
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCTOFOAM HC | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 1%;1% | AEROSOL, METERED;TOPICAL | Prescription | BX | 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 |
|---|---|---|---|---|---|---|---|
| 07/26/1978 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/21/2021 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/11/2003 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 01/03/2003 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/06/2004 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 08/11/2003 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/1999 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/12/1999 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1998 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1995 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/16/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1991 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/28/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/08/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/09/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
PROCTOFOAM HC
There are no Therapeutic Equivalents.