Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210709

TEKTURNA (ALISKIREN HEMIFUMARATE)
EQ 37.5MG BASE Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE
Proprietary Name: TEKTURNA
Dosage Form; Route of Administration: CAPSULE, PELLET; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210709
Product Number: 001
Approval Date: Nov 14, 2017
Applicant Holder Full Name: NODEN PHARMA DAC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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