Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075695
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 2MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 10/23/2001 | 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 |
|---|---|---|---|---|---|
| 10/11/2019 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-21 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/16/2008 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |