Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008317
Company: PARKEDALE
Company: PARKEDALE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTH | CORTICOTROPIN | 25 UNITS/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ACTH | 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 |
|---|---|---|---|---|---|---|---|
| 03/14/1952 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/25/1996 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/23/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 01/19/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/01/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/12/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/08/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/30/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |