Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019030
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRETYLIUM TOSYLATE | BRETYLIUM TOSYLATE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/16/1986 | 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 |
|---|---|---|---|---|---|
| 02/07/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/26/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 10/15/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/26/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/13/1998 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/07/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/26/1996 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/04/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/20/1990 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/04/1990 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/22/1988 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |