Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089601
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METADATE ER METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;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
06/01/1988 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-31 Labeling-Package Insert

Label is not available on this site.

01/21/2016 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

08/31/2011 SUPPL-29 Labeling

Label is not available on this site.

01/21/2016 SUPPL-28 Labeling

Label is not available on this site.

01/21/2016 SUPPL-27 Labeling

Label is not available on this site.

01/21/2016 SUPPL-25 Labeling

Label is not available on this site.

01/21/2016 SUPPL-24 Labeling

Label is not available on this site.

01/21/2016 SUPPL-23 Labeling

Label is not available on this site.

12/28/2005 SUPPL-22 Labeling

Label is not available on this site.

12/09/2002 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/09/2002 SUPPL-16 Labeling

Label is not available on this site.

10/23/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1999 SUPPL-14 Labeling

Label is not available on this site.

10/20/1999 SUPPL-12 Labeling

Label is not available on this site.

02/22/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/08/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/08/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/13/1998 SUPPL-7 Labeling

Label is not available on this site.

07/02/1996 SUPPL-6 Labeling

Label is not available on this site.

09/11/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/25/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/21/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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