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Last Updated: April 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210207


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NDA 210207 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 210207
Tradename:CINACALCET HYDROCHLORIDE
Applicant:Piramal Hlthcare Uk
Ingredient:cinacalcet hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210207
Medical Subject Heading (MeSH) Categories for 210207
Suppliers and Packaging for NDA: 210207
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210207 ANDA Slate Run Pharmaceuticals 70436-007 70436-007-04 30 TABLET, FILM COATED in 1 BOTTLE (70436-007-04)
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210207 ANDA Slate Run Pharmaceuticals 70436-008 70436-008-04 30 TABLET, FILM COATED in 1 BOTTLE (70436-008-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Aug 1, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Aug 1, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:Aug 1, 2018TE:ABRLD:No

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