Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088625
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 08/23/1984 | 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-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/03/1998 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 08/19/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/08/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 12/19/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 10/16/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/16/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 05/04/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/04/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/27/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/27/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |