Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020859
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SONATA ZALEPLON 5MG CAPSULE;ORAL Prescription AB Yes No
SONATA ZALEPLON 10MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/13/1999 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20859lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20859ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20859_Sonata.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2012 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/19/2013 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020859s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020859Orig1s013ltr.pdf
06/17/2009 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

12/11/2007 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020859s009, s011ltr.pdf
12/11/2007 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020859s009, s011ltr.pdf
05/19/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20859slr004,005ltr.pdf
05/19/2003 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20859slr004,005ltr.pdf
05/31/2002 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20859s002ltr.pdf
05/31/2002 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20859s002ltr.pdf
02/22/2001 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20859S1LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20859S1LTR.PDF
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/19/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020859s013lbl.pdf
12/11/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s011lbl.pdf
12/11/2007 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s009lbl.pdf
02/22/2001 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20859S1LBL.PDF
08/13/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20859lbl.pdf

SONATA

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SONATA ZALEPLON 5MG CAPSULE;ORAL Prescription Yes AB 020859 PFIZER
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 078829 AUROBINDO PHARMA
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 077505 CIPLA LTD
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 078147 HIKMA PHARMS
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 090374 ORCHID HLTHCARE
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 077239 TEVA PHARMS
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 078989 UNICHEM
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 077237 WEST-WARD PHARMS INT

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SONATA ZALEPLON 10MG CAPSULE;ORAL Prescription Yes AB 020859 PFIZER
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 078829 AUROBINDO PHARMA
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 077505 CIPLA LTD
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 078147 HIKMA PHARMS
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 090374 ORCHID HLTHCARE
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 077239 TEVA PHARMS
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 078989 UNICHEM
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 077237 WEST-WARD PHARMS INT

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