Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009854
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTROPHIN-ZINC | CORTICOTROPIN-ZINC HYDROXIDE | 40 UNITS/ML | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/1955 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 01/02/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1987 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/07/1986 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/07/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/08/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |