Drugs@FDA: FDA-Approved Drugs
Company: VALEANT PHARM INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVO-DROMORAN | LEVORPHANOL 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 |
---|---|---|---|---|---|---|---|
01/08/1953 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
12/05/2000 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/24/2000 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/13/1999 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/26/1998 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/15/1994 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/15/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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09/27/1989 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/09/1989 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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09/03/1985 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/23/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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02/26/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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06/07/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
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09/20/1983 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/19/1983 | SUPPL-19 | Labeling |
Label is not available on this site. |
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05/16/1983 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/03/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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09/08/1981 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/27/1981 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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11/15/1978 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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02/07/1978 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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12/19/1991 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |