Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086365
Company: VIRTUS
Company: VIRTUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | 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 |
---|---|---|---|---|---|---|---|
09/24/1981 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/13/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
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01/16/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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01/16/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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01/16/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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12/14/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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01/17/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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09/17/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |