Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206125

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CINACALCET HYDROCHLORIDE (CINACALCET HYDROCHLORIDE)
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: A206125
Product Number: 001
Approval Date: Mar 8, 2018
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

CINACALCET HYDROCHLORIDE (CINACALCET HYDROCHLORIDE)
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: A206125
Product Number: 002
Approval Date: Mar 8, 2018
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

CINACALCET HYDROCHLORIDE (CINACALCET HYDROCHLORIDE)
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: A206125
Product Number: 003
Approval Date: Mar 8, 2018
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information