Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012697
Company: VALEANT PHARM INTL
Company: VALEANT PHARM INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRISORALEN | TRIOXSALEN | 5MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
07/24/1964 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
09/23/1997 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/09/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/14/1985 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/16/1984 | SUPPL-11 | Labeling |
Label is not available on this site. |
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08/01/1980 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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11/26/1979 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/09/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
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07/09/1976 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |