Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087796
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTISONE | HYDROCORTISONE | 1% | OINTMENT;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 |
|---|---|---|---|---|---|---|---|
| 10/13/1982 | 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 |
|---|---|---|---|---|---|
| 04/26/2001 | SUPPL-15 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/26/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/07/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/24/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/09/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/04/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 07/26/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/17/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/12/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/11/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |