Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 213931

Expand all

XPHOZAH (TENAPANOR HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: TENAPANOR HYDROCHLORIDE
Proprietary Name: XPHOZAH
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213931
Product Number: 002
Approval Date: Oct 17, 2023
Applicant Holder Full Name: ARDELYX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XPHOZAH (TENAPANOR HYDROCHLORIDE)
EQ 30MG BASE
Marketing Status: Prescription

Active Ingredient: TENAPANOR HYDROCHLORIDE
Proprietary Name: XPHOZAH
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213931
Product Number: 003
Approval Date: Oct 17, 2023
Applicant Holder Full Name: ARDELYX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XPHOZAH (TENAPANOR HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Discontinued

Active Ingredient: TENAPANOR HYDROCHLORIDE
Proprietary Name: XPHOZAH
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213931
Product Number: 001
Approval Date: Oct 17, 2023
Applicant Holder Full Name: ARDELYX INC
Marketing Status:  Discontinued
Patent and Exclusivity Information