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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201961
Company: LANNETT CO INC
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
07/20/2011 ORIG-1 Approval Not Applicable

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-7 Labeling-Package Insert

Label is not available on this site.

12/05/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/20/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

02/14/2012 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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