Drugs@FDA: FDA-Approved Drugs
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPIFOAM | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 1%;1% | AEROSOL, METERED;TOPICAL | Prescription | BX | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/1979 | 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 |
|---|---|---|---|---|---|
| 04/09/2021 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/11/2003 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 01/03/2003 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/06/2004 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 11/29/1999 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/12/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/06/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/18/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/12/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/12/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/16/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/30/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/09/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
EPIFOAM
There are no Therapeutic Equivalents.