Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019005
Company: ABBOTT
Company: ABBOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRETYLIUM TOSYLATE IN DEXTROSE 5% | BRETYLIUM TOSYLATE | 800MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% | BRETYLIUM TOSYLATE | 200MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% | BRETYLIUM TOSYLATE | 400MG/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/16/1986 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |