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Details for New Drug Application (NDA): 208573

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NDA 208573 describes VENCLEXTA, which is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VENCLEXTA profile page.

The generic ingredient in VENCLEXTA is venetoclax. One supplier is listed for this compound. Additional details are available on the venetoclax profile page.

Summary for NDA: 208573

Abbvie Inc

Pharmacology for NDA: 208573

Mechanism of ActionP-Glycoprotein Inhibitors
Physiological EffectIncreased Cellular Death

Suppliers and Packaging for NDA: 208573

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 208573 NDA AbbVie Inc. 0074-0561 0074-0561-11 1 BLISTER PACK in 1 CARTON (0074-0561-11) > 2 TABLET, FILM COATED in 1 BLISTER PACK
TABLET;ORAL 208573 NDA AbbVie Inc. 0074-0561 0074-0561-14 1 BLISTER PACK in 1 CARTON (0074-0561-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 11, 2016TE:RLD:No
Patent:8,546,399Patent Expiration:Jun 27, 2031Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Apr 11, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 11, 2023
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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