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Details for New Drug Application (NDA): 021991

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NDA 021991 describes ZOLINZA, which is a drug marketed by Merck and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the ZOLINZA profile page.

The generic ingredient in ZOLINZA is vorinostat. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the vorinostat profile page.

Summary for NDA: 021991

Tradename:
ZOLINZA
Applicant:
Merck
Ingredient:
vorinostat
Patents:10
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021991

Suppliers and Packaging for NDA: 021991

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLINZA
vorinostat
CAPSULE;ORAL 021991 NDA Merck Sharp & Dohme Corp. 0006-0568 0006-0568-40 120 CAPSULE in 1 BOTTLE (0006-0568-40)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Oct 6, 2006TE:RLD:Yes
Patent:7,456,219Patent Expiration:Mar 11, 2027Product Flag?Substance Flag?YDelist Request?
Patent:7,652,069Patent Expiration:Mar 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:8,093,295Patent Expiration:May 16, 2026Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021991

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
ZOLINZA
vorinostat
CAPSULE;ORAL021991-001Oct 6, 20066,087,367► subscribe
Merck
ZOLINZA
vorinostat
CAPSULE;ORAL021991-001Oct 6, 2006RE38506► subscribe
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