Product Details for ANDA 210207
CINACALCET HYDROCHLORIDE (CINACALCET HYDROCHLORIDE)
EQ 30MG BASE
Marketing Status: Prescription
EQ 60MG BASE
Marketing Status: Prescription
EQ 90MG BASE
Marketing Status: Prescription
EQ 30MG BASE
Marketing Status: Prescription
Active Ingredient: CINACALCET HYDROCHLORIDE
Proprietary Name: CINACALCET HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210207
Product Number: 001
Approval Date: Aug 1, 2018
Applicant Holder Full Name: SLATE RUN PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CINACALCET HYDROCHLORIDE (CINACALCET HYDROCHLORIDE)
Proprietary Name: CINACALCET HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210207
Product Number: 001
Approval Date: Aug 1, 2018
Applicant Holder Full Name: SLATE RUN PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 60MG BASE
Marketing Status: Prescription
Active Ingredient: CINACALCET HYDROCHLORIDE
Proprietary Name: CINACALCET HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210207
Product Number: 002
Approval Date: Aug 1, 2018
Applicant Holder Full Name: SLATE RUN PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CINACALCET HYDROCHLORIDE (CINACALCET HYDROCHLORIDE)
Proprietary Name: CINACALCET HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210207
Product Number: 002
Approval Date: Aug 1, 2018
Applicant Holder Full Name: SLATE RUN PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 90MG BASE
Marketing Status: Prescription
Active Ingredient: CINACALCET HYDROCHLORIDE
Proprietary Name: CINACALCET HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 90MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210207
Product Number: 003
Approval Date: Aug 1, 2018
Applicant Holder Full Name: SLATE RUN PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CINACALCET HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 90MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210207
Product Number: 003
Approval Date: Aug 1, 2018
Applicant Holder Full Name: SLATE RUN PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information