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Generated: January 18, 2019

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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 nine 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 021991
Tradename:ZOLINZA
Applicant:Merck
Ingredient:vorinostat
Patents:9
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021991
Generic Entry Date for 021991*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Oct 6, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 9, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA (CTCL)
Patent:➤ Sign UpPatent Expiration:Mar 11, 2027Product Flag?Substance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Mar 4, 2023Product Flag?YSubstance Flag?Delist Request?

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