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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 208368


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NDA 208368 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 208368
Tradename:CINACALCET HYDROCHLORIDE
Applicant:Dr Reddys
Ingredient:cinacalcet hydrochloride
Patents:0
Pharmacology for NDA: 208368
Medical Subject Heading (MeSH) Categories for 208368
Suppliers and Packaging for NDA: 208368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 208368 ANDA Dr. Reddys Laboratories Inc 43598-367 43598-367-05 500 TABLET in 1 BOTTLE (43598-367-05)
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 208368 ANDA Dr. Reddys Laboratories Inc 43598-367 43598-367-30 30 TABLET in 1 BOTTLE (43598-367-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Sep 18, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Sep 18, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:Sep 18, 2020TE:ABRLD:No

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