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Details for New Drug Application (NDA): 206843

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NDA 206843 describes DAKLINZA, which is a drug marketed by Bristol-myers Squibb and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DAKLINZA profile page.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the daclatasvir dihydrochloride profile page.

Suppliers and Packaging for NDA: 206843

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL 206843 NDA E.R. Squibb & Sons, L.L.C. 0003-0011 0003-0011-01 28 TABLET in 1 BOTTLE (0003-0011-01)
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL 206843 NDA E.R. Squibb & Sons, L.L.C. 0003-0213 0003-0213-01 28 TABLET in 1 BOTTLE (0003-0213-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jul 24, 2015TE:RLD:No
Patent:8,329,159Patent Expiration:Apr 13, 2028Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Feb 5, 2019
Regulatory Exclusivity Use:DOSAGE RECOMMENDATIONS ADDED TO INCLUDE TREATMENT OF HCV GENOTYPE 3 SUBJECTS CO-INFECTED WITH HIV-1
Regulatory Exclusivity Expiration:Feb 5, 2019
Regulatory Exclusivity Use:DOSING TO INCLUDE PATIENTS WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH COMPENSATED (CHILD-PUGH A) OR DECOMPENSATED (CHILD-PUGH B OR C) CIRRHOSIS AND TREATMENT OF CHRONIC HCV GENOTYPE 3 INFECTION IN SUBJECTS WITH DECOMPENSATED (CHILD-PUGH B OR C) CIRRHOSIS


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