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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020859
Company: PFIZER

Medication Guide

Other Important Information from FDA

Products on NDA 020859

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020859

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
08/18/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020859Orig1s016ltr_rev1rev2LNF.pdf
02/06/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020859Orig1s015ltr.pdf
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

Labels for NDA 020859

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s016lbl.pdf
02/06/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s015lbl.pdf
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

Therapeutic Equivalents for NDA 020859

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	CHARTWELL MOLECULAR
ZALEPLON	ZALEPLON	5MG	CAPSULE;ORAL	Prescription	No	AB	077237	HIKMA
ZALEPLON	ZALEPLON	5MG	CAPSULE;ORAL	Prescription	No	AB	090374	ORBION PHARMS
ZALEPLON	ZALEPLON	5MG	CAPSULE;ORAL	Prescription	No	AB	078989	UNICHEM

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	CHARTWELL MOLECULAR
ZALEPLON	ZALEPLON	10MG	CAPSULE;ORAL	Prescription	No	AB	077237	HIKMA
ZALEPLON	ZALEPLON	10MG	CAPSULE;ORAL	Prescription	No	AB	090374	ORBION PHARMS
ZALEPLON	ZALEPLON	10MG	CAPSULE;ORAL	Prescription	No	AB	078989	UNICHEM

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