Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012095
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORINASE DIAGNOSTIC | TOLBUTAMIDE SODIUM | EQ 1GM BASE/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 |
|---|---|---|---|---|---|---|---|
| 06/22/1961 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/04/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1995 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/21/1983 | SUPPL-15 | Labeling |
Label is not available on this site. |