Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086257
Company: SUN PHARMA CANADA
Company: SUN PHARMA CANADA
| 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 |
|---|---|---|---|---|---|---|---|
| 07/24/1978 | 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 |
|---|---|---|---|---|---|
| 04/29/1993 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/19/1992 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 04/16/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 11/21/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/07/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/11/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 07/24/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/08/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/26/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/03/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/24/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |