Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083903
Company: LANNETT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Discontinued None No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 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
10/29/1975 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
01/04/2017 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

04/17/2015 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/08/2003 SUPPL-24 Labeling

Label is not available on this site.

09/19/1991 SUPPL-19 Labeling

Label is not available on this site.

12/17/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/19/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/19/1991 SUPPL-16 Labeling

Label is not available on this site.

06/05/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/03/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/13/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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