Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085938
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTABARBITAL SODIUM | BUTABARBITAL SODIUM | 15MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/1994 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/07/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |