Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084051
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSTAT DEXTROAMPHETAMINE SULFATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
DEXTROSTAT DEXTROAMPHETAMINE SULFATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
05/29/1975 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
11/20/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/2002 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

02/28/2000 SUPPL-22 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/27/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/26/1998 SUPPL-20 Labeling

Label is not available on this site.

04/15/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-18 Labeling

Label is not available on this site.

09/26/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/26/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/18/1997 SUPPL-15 Labeling

Label is not available on this site.

02/28/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/18/1997 SUPPL-13 Labeling

Label is not available on this site.

01/09/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/08/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/08/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/29/1990 SUPPL-9 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English