Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007600
Company: PARKEDALE
Company: PARKEDALE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SURITAL | THIAMYLAL SODIUM | 1GM/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| SURITAL | THIAMYLAL SODIUM | 5GM/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| SURITAL | THIAMYLAL SODIUM | 10GM/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 |
|---|---|---|---|---|---|---|---|
| 07/09/1954 | 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 |
|---|---|---|---|---|---|
| 09/17/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/17/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 06/20/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/05/1970 | SUPPL-1 | Labeling |
Label is not available on this site. |