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Serving 500+ biopharmaceutical companies globally:

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US Department of Justice
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Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020859

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NDA 020859 describes SONATA, which is a drug marketed by Pfizer and is included in one NDA. It is available from six suppliers. Additional details are available on the SONATA profile page.

The generic ingredient in SONATA is zaleplon. There are twelve drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for NDA: 020859

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 020859

Suppliers and Packaging for NDA: 020859

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SONATA
zaleplon
CAPSULE;ORAL 020859 NDA Rebel Distributors Corp. 21695-105 21695-105-14 14 CAPSULE in 1 BOTTLE, PLASTIC (21695-105-14)
SONATA
zaleplon
CAPSULE;ORAL 020859 NDA Rebel Distributors Corp. 21695-105 21695-105-30 30 CAPSULE in 1 BOTTLE, PLASTIC (21695-105-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Aug 13, 1999TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Aug 13, 1999TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020859

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
SONATA
zaleplon
CAPSULE;ORAL020859-001Aug 13, 19994,626,538► Subscribe
Pfizer
SONATA
zaleplon
CAPSULE;ORAL020859-002Aug 13, 19994,626,538► Subscribe
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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Covington
Mallinckrodt
Citi
Harvard Business School
Healthtrust
Federal Trade Commission
UBS
Queensland Health
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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