Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010942
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPARINE | PROMAZINE HYDROCHLORIDE | 30MG/ML | CONCENTRATE;ORAL | Discontinued | None | No | No |
| SPARINE | PROMAZINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Discontinued | None | No | No |
| SPARINE | PROMAZINE HYDROCHLORIDE | 100MG/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 11/12/1957 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 02/24/1978 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |