Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020547
Company: PAR PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACCOLATE ZAFIRLUKAST 20MG TABLET;ORAL Prescription AB Yes Yes
ACCOLATE ZAFIRLUKAST 10MG TABLET;ORAL Prescription AB 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
09/26/1996 ORIG-1 Approval Type 1 - New Molecular Entity 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
03/29/2016 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/15/2013 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020547s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020547Orig1s033ltr.pdf
05/15/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/08/2011 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020547s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020547s031ltr.pdf
10/13/2010 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s030ltr.pdf
07/14/2010 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s029ltr.pdf
08/21/2009 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020547s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020547s027ltr.pdf
05/29/2008 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020547s025ltr.pdf
06/06/2005 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020547s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020547s022ltr.pdf
03/26/2004 SUPPL-19 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20547slr019_accolate_lbl.pdf
10/31/2003 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20547slr017ltr.pdf
01/08/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/19/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/27/2001 SUPPL-14 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20547s014ltr.pdf
06/12/2000 SUPPL-13 Labeling

Label is not available on this site.

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

Label is not available on this site.

02/07/2000 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20547-S011_Accolate.pdf
09/09/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/30/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/17/1999 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20547-s008_accolate.pdf
09/17/1999 SUPPL-7 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20547s07ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-547-S007_Accolate.cfm
08/17/1998 SUPPL-6 Labeling

Label is not available on this site.

05/06/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/23/1998 SUPPL-4 Labeling

Label is not available on this site.

05/06/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/10/1997 SUPPL-2 Labeling

Label is not available on this site.

04/28/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020547s033lbl.pdf
08/08/2011 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020547s031lbl.pdf
10/13/2010 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s030lbl.pdf
07/14/2010 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s029lbl.pdf
08/21/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020547s027lbl.pdf
06/06/2005 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020547s022lbl.pdf
03/26/2004 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20547slr019_accolate_lbl.pdf

ACCOLATE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCOLATE ZAFIRLUKAST 20MG TABLET;ORAL Prescription Yes AB 020547 PAR PHARM INC
ZAFIRLUKAST ZAFIRLUKAST 20MG TABLET;ORAL Prescription No AB 090372 DR REDDYS LABS LTD

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCOLATE ZAFIRLUKAST 10MG TABLET;ORAL Prescription Yes AB 020547 PAR PHARM INC
ZAFIRLUKAST ZAFIRLUKAST 10MG TABLET;ORAL Prescription No AB 090372 DR REDDYS LABS LTD

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