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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208573

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VENCLEXTA (VENETOCLAX)
10MG
Marketing Status: Prescription
Active Ingredient: VENETOCLAX
Proprietary Name: VENCLEXTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208573
Product Number: 001
Approval Date: Apr 11, 2016
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VENCLEXTA (VENETOCLAX)
50MG
Marketing Status: Prescription
Active Ingredient: VENETOCLAX
Proprietary Name: VENCLEXTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208573
Product Number: 002
Approval Date: Apr 11, 2016
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VENCLEXTA (VENETOCLAX)
100MG
Marketing Status: Prescription
Active Ingredient: VENETOCLAX
Proprietary Name: VENCLEXTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208573
Product Number: 003
Approval Date: Apr 11, 2016
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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