Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080443
Company: DOW PHARM
Company: DOW PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUTRACORT | HYDROCORTISONE | 0.5% | LOTION;TOPICAL | Discontinued | None | No | No |
| NUTRACORT | HYDROCORTISONE | 1% | LOTION;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 |
|---|---|---|---|---|---|---|---|
| 04/26/1972 | 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 |
|---|---|---|---|---|---|
| 07/15/2002 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/23/2001 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1993 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 02/11/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 07/26/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/21/1988 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 11/21/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/21/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/25/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |