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Last Updated: August 4, 2020

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Details for New Drug Application (NDA): 204377

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NDA 204377 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 204377
Applicant:Watson Labs Teva
Ingredient:cinacalcet hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 204377
Medical Subject Heading (MeSH) Categories for 204377
Suppliers and Packaging for NDA: 204377
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 204377 ANDA Actavis Pharma, Inc. 0591-2417 0591-2417-30 30 TABLET, FILM COATED in 1 BOTTLE (0591-2417-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Dec 27, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Dec 27, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:Dec 27, 2018TE:ABRLD:No

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