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Generated: June 25, 2019

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Details for New Drug Application (NDA): 203422

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NDA 203422 describes CINACALCET HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Cipla, Mylan, Piramal Hlthcare Uk, Strides Pharma, Sun Pharm, and Watson Labs Teva, and is included in eight NDAs. It is available from seven 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. Eleven suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
Summary for 203422
Tradename:CINACALCET HYDROCHLORIDE
Applicant:Mylan
Ingredient:cinacalcet hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203422
Medical Subject Heading (MeSH) Categories for 203422
Suppliers and Packaging for NDA: 203422
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 203422 ANDA Mylan Pharmaceuticals Inc. 0378-6195 0378-6195-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6195-93)
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 203422 ANDA Mylan Pharmaceuticals Inc. 0378-6196 0378-6196-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6196-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Oct 16, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Oct 16, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:Oct 16, 2018TE:ABRLD:No

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