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Generated: March 20, 2019

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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 two 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-two suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
Summary for 020859
Tradename:SONATA
Applicant:Pfizer
Ingredient:zaleplon
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020859
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
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)

Profile for product number 001

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

Profile for product number 002

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

Expired US Patents for NDA 020859

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer SONATA zaleplon CAPSULE;ORAL 020859-001 Aug 13, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer SONATA zaleplon CAPSULE;ORAL 020859-002 Aug 13, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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