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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214200

COSELA (TRILACICLIB DIHYDROCHLORIDE)
EQ 300MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: TRILACICLIB DIHYDROCHLORIDE
Proprietary Name: COSELA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 300MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214200
Product Number: 001
Approval Date: Feb 12, 2021
Applicant Holder Full Name: G1 THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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