Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040555
Company: LANNETT
Company: LANNETT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | 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 |
---|---|---|---|---|---|---|---|
04/15/2005 | 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 |
---|---|---|---|---|---|
05/31/2017 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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12/05/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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04/27/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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08/22/2011 | SUPPL-8 | Labeling-Container/Carton Labels |
Label is not available on this site. |