Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083922
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAM-METRAZINE | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/1976 | 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-61 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/22/1994 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/20/1991 | SUPPL-57 | Labeling |
Label is not available on this site. |
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| 09/15/1989 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 06/27/1988 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1984 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/04/1984 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/13/1989 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1983 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/13/1989 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1983 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |