Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007504
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTHAR | CORTICOTROPIN | 25 UNITS/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ACTHAR | CORTICOTROPIN | 40 UNITS/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/1950 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/20/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 08/24/1983 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 03/26/1981 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 06/26/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/26/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 10/05/1977 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 05/25/1977 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/30/1975 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 10/03/1975 | SUPPL-9 | Labeling |
Label is not available on this site. |