Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087022
Company: LANNETT
Company: LANNETT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/03/1983 | 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-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/14/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/05/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/19/2012 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/19/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/27/2010 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2010 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 01/20/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/06/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |