Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012254
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TINDAL | ACETOPHENAZINE MALEATE | 20MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 04/05/1961 | 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 |
|---|---|---|---|---|---|
| 08/29/1986 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 06/18/1981 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/18/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 06/20/1980 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |