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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 204364


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NDA 204364 describes CINACALCET HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, Norvium Bioscience, Slate Run Pharma, Stevens J, Strides Pharma, Sun Pharm, and Watson Labs Teva, and is included in fourteen NDAs. It is available from eighteen 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. Twenty suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
Summary for 204364
Tradename:CINACALCET HYDROCHLORIDE
Applicant:Stevens J
Ingredient:cinacalcet hydrochloride
Patents:0
Pharmacology for NDA: 204364
Medical Subject Heading (MeSH) Categories for 204364
Suppliers and Packaging for NDA: 204364
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 204364 ANDA Amneal Pharmaceuticals LLC 65162-155 65162-155-03 30 TABLET in 1 BOTTLE (65162-155-03)
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 204364 ANDA Amneal Pharmaceuticals LLC 65162-155 65162-155-10 100 TABLET in 1 BOTTLE (65162-155-10)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength30MG
Approval Date:Dec 2, 2021TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength60MG
Approval Date:Dec 2, 2021TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength90MG
Approval Date:Dec 2, 2021TE:RLD:No

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