Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017551
Company: MALLINCKRODT
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERCHLORACAP | POTASSIUM PERCHLORATE | 200MG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/21/1974 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 06/30/1994 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/27/1977 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/14/1976 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |