Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019121
Company: B BRAUN
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER | BRETYLIUM TOSYLATE | 100MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER | BRETYLIUM TOSYLATE | 200MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER | 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 |
---|---|---|---|---|---|---|---|
04/29/1986 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
10/06/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/13/1990 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |