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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 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-four suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for NDA: 020859

Therapeutic Class:Sedatives/Hypnotics

Pharmacology for NDA: 020859

Suppliers and Packaging for NDA: 020859

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 020859 NDA Rebel Distributors Corp. 21695-105 21695-105-14 14 CAPSULE in 1 BOTTLE, PLASTIC (21695-105-14)
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:No

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CAPSULE;ORAL020859-001Aug 13, 19994,626,538<disabled>
CAPSULE;ORAL020859-002Aug 13, 19994,626,538<disabled>
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