Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011522
Company: TEVA WOMENS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADDERALL 10 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ADDERALL 12.5 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ADDERALL 15 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ADDERALL 20 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ADDERALL 30 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ADDERALL 5 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ADDERALL 7.5 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
01/19/1960 ORIG-1 Approval Type 2 New Active Ingredient and Type 4 New Combination STANDARD

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-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011522s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011522Orig1s043ltr.pdf
10/01/2015 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011522Orig1s042ltr.pdf
04/17/2015 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011522Orig1s041ltr.pdf
06/07/2007 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011522s040ltr.pdf
07/26/2006 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf
07/26/2006 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf
08/02/2005 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011522s032,033ltr.pdf
08/02/2005 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011522s032,033ltr.pdf
11/08/2002 SUPPL-30 Manufacturing (CMC)-Formulation Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11522scf030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/11-522S030_Adderall.cfm
04/11/2002 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/10/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/15/2000 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/26/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/20/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1999 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/23/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/16/1998 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1998 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1997 SUPPL-17 Labeling

Label is not available on this site.

11/14/1997 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1997 SUPPL-15 Labeling

Label is not available on this site.

06/13/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/29/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1997 SUPPL-11 Labeling

Label is not available on this site.

02/13/1996 SUPPL-10 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/11522S010_Adderall.pdf
02/13/1996 SUPPL-9 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011522s043lbl.pdf
10/01/2015 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s042lbl.pdf
04/17/2015 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s041lbl.pdf
06/07/2007 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf
07/26/2006 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf
07/26/2006 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf
08/02/2005 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf
08/02/2005 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf

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