Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020381
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIASPAN NIACIN 375MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
NIASPAN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
NIASPAN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
NIASPAN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
NIASPAN TITRATION STARTER PACK NIACIN 375MG;500MG;750MG TABLET, EXTENDED RELEASE;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
07/28/1997 ORIG-1 Approval Type 3 - New Dosage Form 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
10/28/2015 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

04/27/2015 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020381Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020381Orig1s051ltr.pdf
05/27/2015 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

06/18/2013 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/21/2013 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020381s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020381Orig1s048,022078Orig1s015ltr.pdf
11/09/2010 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s043ltr.pdf
02/24/2010 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s042ltr.pdf
09/16/2009 SUPPL-41 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf
09/16/2009 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf
03/26/2009 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s038ltr.pdf
12/18/2007 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020381s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s034ltr.pdf
05/29/2008 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf
04/04/2007 SUPPL-27 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s027ltr.pdf
04/11/2006 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020381s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020381s025ltr.pdf
09/09/2005 SUPPL-23 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s023ltr.pdf
06/08/2005 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s020ltr.pdf
09/05/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/2003 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020381s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20381se1-013ltr.pdf
11/24/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/02/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/13/1999 SUPPL-7 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381s07ltr.pdf
10/28/1999 SUPPL-6 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381S6LTR.PDF
08/24/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/12/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/02/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1998 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
04/27/2015 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020381Orig1s051lbl.pdf
02/21/2013 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020381s048lbl.pdf
11/09/2010 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s043lbl.pdf
02/24/2010 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s042lbl.pdf
09/16/2009 SUPPL-41 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf
09/16/2009 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf
09/16/2009 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf
12/18/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020381s034lbl.pdf
04/11/2006 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020381s025lbl.pdf
09/09/2005 SUPPL-23 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s023lbl.pdf
06/08/2005 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s020lbl.pdf
01/31/2003 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020381s013lbl.pdf

NIASPAN

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203578 AMNEAL PHARMS
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209236 AUROBINDO PHARMA LTD
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076378 BARR
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209156 JUBILANT GENERICS
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203899 LANNETT CO INC
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090860 LUPIN LTD
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203742 MYLAN
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200484 SUN PHARM
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212017 YICHANG HUMANWELL
NIASPAN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020381 ABBVIE

TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204178 AMNEAL PHARMS
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209236 AUROBINDO PHARMA LTD
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076378 BARR
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209156 JUBILANT GENERICS
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090892 LUPIN LTD
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203742 MYLAN
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201273 SUN PHARM
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212017 YICHANG HUMANWELL
NIASPAN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020381 ABBVIE

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203578 AMNEAL PHARMS
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209236 AUROBINDO PHARMA LTD
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076250 BARR
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209156 JUBILANT GENERICS
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203899 LANNETT CO INC
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090446 LUPIN LTD
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203742 MYLAN
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200484 SUN PHARM
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212017 YICHANG HUMANWELL
NIASPAN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020381 ABBVIE

NIASPAN TITRATION STARTER PACK

There are no Therapeutic Equivalents.

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