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Last Updated: May 25, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210570


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NDA 210570 describes CINACALCET HYDROCHLORIDE, which is a drug marketed by 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 nine NDAs. It is available from ten 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. Twelve suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
Summary for 210570
Tradename:CINACALCET HYDROCHLORIDE
Applicant:Alkem Labs Ltd
Ingredient:cinacalcet hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210570
Medical Subject Heading (MeSH) Categories for 210570
Suppliers and Packaging for NDA: 210570
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210570 ANDA American Health Packaging 60687-525 60687-525-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-525-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-525-11)
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210570 ANDA Ascend Laboratories, LLC 67877-503 67877-503-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-503-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:May 17, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:May 17, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:May 17, 2019TE:ABRLD:No

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