Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020632
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MERIDIA SIBUTRAMINE HYDROCHLORIDE 5MG CAPSULE;ORAL Discontinued None No No
MERIDIA SIBUTRAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Discontinued None No No
MERIDIA SIBUTRAMINE HYDROCHLORIDE 15MG CAPSULE;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
11/22/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20632_meridia.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/04/2010 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf
08/04/2010 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf
05/04/2009 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020632s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020632s032ltr.pdf
12/24/2008 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020632s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s031ltr.pdf
05/29/2008 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf
08/23/2006 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020632s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020632s026ltr.pdf
07/29/2005 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s024ltr.pdf
12/08/2005 SUPPL-21 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s021ltr.pdf
11/24/2004 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf
11/24/2004 SUPPL-19 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20632s019,020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf
09/25/2003 SUPPL-17 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20632slr017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020632_S017_MERIDIA_AP.pdf
10/08/2002 SUPPL-15 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S015_MERIDIA.pdf
08/07/2002 SUPPL-14 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S014_MERIDIA.pdf
04/25/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/16/2001 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf
02/16/2001 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf
11/12/1999 SUPPL-6 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S006_MERIDIA_CAPSULES.pdf
07/06/1999 SUPPL-4 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S004_MERIDA_CAPSULES.pdf
08/07/1998 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020632_S002_MERIDIA_CAPSULES.pdf
08/07/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/04/2010 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf
08/04/2010 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf
05/04/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020632s032lbl.pdf
12/24/2008 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020632s031lbl.pdf
08/23/2006 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020632s026lbl.pdf
12/08/2005 SUPPL-21 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s021lbl.pdf
07/29/2005 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s024lbl.pdf
11/24/2004 SUPPL-19 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20632s019,020lbl.pdf
02/16/2001 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf
02/16/2001 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf

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