Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208716

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VERZENIO (ABEMACICLIB)
50MG
Marketing Status: Prescription

Active Ingredient: ABEMACICLIB
Proprietary Name: VERZENIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208716
Product Number: 001
Approval Date: Sep 28, 2017
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

VERZENIO (ABEMACICLIB)
100MG
Marketing Status: Prescription

Active Ingredient: ABEMACICLIB
Proprietary Name: VERZENIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208716
Product Number: 002
Approval Date: Sep 28, 2017
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

VERZENIO (ABEMACICLIB)
150MG
Marketing Status: Prescription

Active Ingredient: ABEMACICLIB
Proprietary Name: VERZENIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208716
Product Number: 003
Approval Date: Sep 28, 2017
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

VERZENIO (ABEMACICLIB)
200MG
Marketing Status: Prescription

Active Ingredient: ABEMACICLIB
Proprietary Name: VERZENIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208716
Product Number: 004
Approval Date: Sep 28, 2017
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information