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Last Updated: April 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209226


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NDA 209226 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 209226
Tradename:CINACALCET HYDROCHLORIDE
Applicant:Strides Pharma
Ingredient:cinacalcet hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209226
Medical Subject Heading (MeSH) Categories for 209226
Suppliers and Packaging for NDA: 209226
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 209226 ANDA Strides Pharma Science Limited 64380-883 64380-883-04 30 TABLET, FILM COATED in 1 BOTTLE (64380-883-04)
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 209226 ANDA Strides Pharma Science Limited 64380-884 64380-884-04 30 TABLET, FILM COATED in 1 BOTTLE (64380-884-04)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Apr 30, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:Apr 30, 2018TE:ABRLD:No

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