Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085799
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG 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
12/23/1977 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
01/21/2016 SUPPL-45 Labeling-Medication Guide

Label is not available on this site.

01/21/2016 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

01/21/2016 SUPPL-43 Labeling

Label is not available on this site.

01/21/2016 SUPPL-42 Labeling

Label is not available on this site.

01/21/2016 SUPPL-41 Labeling

Label is not available on this site.

01/21/2016 SUPPL-39 Labeling

Label is not available on this site.

01/21/2016 SUPPL-38 Labeling

Label is not available on this site.

01/21/2016 SUPPL-37 Labeling

Label is not available on this site.

12/28/2005 SUPPL-36 Labeling

Label is not available on this site.

07/19/2004 SUPPL-35 Labeling

Label is not available on this site.

12/09/2002 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/09/2002 SUPPL-31 Labeling

Label is not available on this site.

11/08/1999 SUPPL-30 Labeling

Label is not available on this site.

11/24/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/24/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/24/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/24/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/13/1998 SUPPL-23 Labeling

Label is not available on this site.

07/02/1996 SUPPL-22 Labeling

Label is not available on this site.

06/30/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/24/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/24/1992 SUPPL-19 Bioequivalence

Label is not available on this site.

05/10/1989 SUPPL-17 Labeling

Label is not available on this site.

12/10/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/10/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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