An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	Discontinued	None	Yes	No
SONATA	ZALEPLON	10MG	CAPSULE;ORAL	Discontinued	None	Yes	No

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.html

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

Top