Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085761
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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 |
|---|---|---|---|---|---|---|---|
| 08/02/1977 | 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 |
|---|---|---|---|---|---|
| 10/06/2000 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 10/24/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/27/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1984 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/24/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1982 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |