Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040306
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METADATE ER METHYLPHENIDATE HYDROCHLORIDE 10MG 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
10/20/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40306_Metadate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40306LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/040306_metadate_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/21/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

01/21/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

01/21/2016 SUPPL-15 Labeling

Label is not available on this site.

01/21/2016 SUPPL-14 Labeling

Label is not available on this site.

01/21/2016 SUPPL-13 Labeling

Label is not available on this site.

01/21/2016 SUPPL-11 Labeling

Label is not available on this site.

01/21/2016 SUPPL-10 Labeling

Label is not available on this site.

01/21/2016 SUPPL-9 Labeling

Label is not available on this site.

12/28/2005 SUPPL-8 Labeling

Label is not available on this site.

12/09/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/09/2002 SUPPL-2 Labeling

Label is not available on this site.

05/01/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/20/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40306_Metadate_Prntlbl.pdf

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