Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085512
Company: ABC HOLDING
Company: ABC HOLDING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENAZINE-35 | 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 |
---|---|---|---|---|---|---|---|
05/06/1977 | 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 |
---|---|---|---|---|---|
12/13/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
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06/27/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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05/18/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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02/29/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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06/09/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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02/11/1983 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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06/09/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |