Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRACRIUM | ATRACURIUM BESYLATE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
TRACRIUM PRESERVATIVE FREE | ATRACURIUM BESYLATE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
11/23/1983 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
03/26/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/03/2000 | SUPPL-22 | Labeling |
Label is not available on this site. |
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10/03/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
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06/08/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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06/06/1994 | SUPPL-19 | Efficacy-New Patient Population |
Label is not available on this site. |
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06/01/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
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10/06/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
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10/06/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
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07/06/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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05/19/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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12/11/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
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10/29/1986 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/29/1986 | SUPPL-11 | Efficacy-New Route Of Administration |
Label is not available on this site. |
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03/13/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
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02/14/1986 | SUPPL-8 | Efficacy-New Patient Population |
Label is not available on this site. |
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10/29/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/13/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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06/24/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/11/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/17/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/20/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
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06/20/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |