Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085319
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 8MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/14/1977 | 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-36 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 06/01/1999 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 04/08/1998 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 12/19/1997 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 10/16/1992 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/27/1988 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/27/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/19/1990 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 05/12/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/04/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/15/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1982 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |