Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084935
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXEDRINE DEXTROAMPHETAMINE SULFATE 5MG 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
02/26/1976 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
08/17/2007 SUPPL-25 Labeling

Label is not available on this site.

08/23/2006 SUPPL-24 Labeling

Label is not available on this site.

11/28/2000 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/2000 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

10/27/1999 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/22/1997 SUPPL-16 Labeling

Label is not available on this site.

08/22/1991 SUPPL-15 Labeling

Label is not available on this site.

08/22/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/17/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/30/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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