Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020333
Company: SHIRE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AGRYLIN ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription AB No No
AGRYLIN ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
03/14/1997 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/14/2015 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020333s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020333Orig1s023ltr.pdf
10/30/2014 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s022ltr.pdf
02/07/2014 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s021ltr.pdf
07/17/2013 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020333s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020333Orig1s020ltr.pdf
11/22/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s019ltr.pdf
01/31/2011 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s017ltr.pdf
06/30/2010 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020333s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020333s016ltr.pdf
07/09/2009 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020333s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020333s015ltr.pdf
06/17/2008 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020333s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020333s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020333Orig1s013.pdf
12/17/2004 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s010ltr.pdf
12/10/2004 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf
12/10/2004 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf
10/10/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/15/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/03/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/13/2000 SUPPL-4 Labeling

Label is not available on this site.

08/19/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/16/1998 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20333S2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20333S2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20333-S002_Agrylin.pdf
11/07/1997 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
07/14/2015 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020333s023lbl.pdf
10/30/2014 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s022lbl.pdf
02/07/2014 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s021lbl.pdf
07/17/2013 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020333s020lbl.pdf
11/22/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s019lbl.pdf
01/31/2011 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s017lbl.pdf
06/30/2010 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020333s016lbl.pdf
07/09/2009 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020333s015lbl.pdf
06/17/2008 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020333s013lbl.pdf
12/17/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf
12/10/2004 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf
12/10/2004 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf
12/16/1998 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20333S2lbl.pdf

AGRYLIN

CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AGRYLIN ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 020333 SHIRE LLC
ANAGRELIDE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 076530 BARR
ANAGRELIDE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 076910 IMPAX LABS
ANAGRELIDE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 076468 IVAX SUB TEVA PHARMS
ANAGRELIDE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 209151 TORRENT PHARMS LTD

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