Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019536
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDERAL | PROPRANOLOL HYDROCHLORIDE | 10MG/ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 12/12/1986 | 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 |
|---|---|---|---|---|---|
| 02/14/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/14/1988 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |