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Last Updated: August 4, 2020

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Details for New Drug Application (NDA): 211892

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NDA 211892 describes CINACALCET HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Acme Labs, Alkem Labs Ltd, Aurobindo Pharma Ltd, Cipla, Lupin Ltd, Mylan, Piramal Hlthcare Uk, Strides Pharma, Sun Pharm, and Watson Labs Teva, and is included in eleven NDAs. It is available from sixteen suppliers. Additional details are available on the CINACALCET HYDROCHLORIDE profile page.

The generic ingredient in CINACALCET HYDROCHLORIDE is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
Summary for 211892
Tradename:CINACALCET HYDROCHLORIDE
Applicant:Accord Hlthcare
Ingredient:cinacalcet hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211892
Medical Subject Heading (MeSH) Categories for 211892
Suppliers and Packaging for NDA: 211892
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 211892 ANDA Accord Healthcare, Inc. 16729-440 16729-440-10 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-440-10)
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 211892 ANDA Accord Healthcare, Inc. 16729-440 16729-440-15 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-440-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:May 15, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:May 15, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:May 15, 2020TE:ABRLD:No

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