Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021985

Expand all

TEKTURNA (ALISKIREN HEMIFUMARATE)
EQ 150MG BASE
Marketing Status: Prescription

Active Ingredient: ALISKIREN HEMIFUMARATE
Proprietary Name: TEKTURNA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021985
Product Number: 001
Approval Date: Mar 5, 2007
Applicant Holder Full Name: NODEN PHARMA DAC
Marketing Status:  Prescription
Patent and Exclusivity Information

TEKTURNA (ALISKIREN HEMIFUMARATE)
EQ 300MG BASE
Marketing Status: Prescription

Active Ingredient: ALISKIREN HEMIFUMARATE
Proprietary Name: TEKTURNA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021985
Product Number: 002
Approval Date: Mar 5, 2007
Applicant Holder Full Name: NODEN PHARMA DAC
Marketing Status:  Prescription
Patent and Exclusivity Information