Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206843

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DAKLINZA (DACLATASVIR DIHYDROCHLORIDE)
EQ 30MG BASE
Marketing Status: Discontinued

Active Ingredient: DACLATASVIR DIHYDROCHLORIDE
Proprietary Name: DAKLINZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206843
Product Number: 001
Approval Date: Jul 24, 2015
Applicant Holder Full Name: BRISTOL-MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

DAKLINZA (DACLATASVIR DIHYDROCHLORIDE)
EQ 60MG BASE
Marketing Status: Discontinued

Active Ingredient: DACLATASVIR DIHYDROCHLORIDE
Proprietary Name: DAKLINZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206843
Product Number: 002
Approval Date: Jul 24, 2015
Applicant Holder Full Name: BRISTOL-MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

DAKLINZA (DACLATASVIR DIHYDROCHLORIDE)
EQ 90MG BASE
Marketing Status: Discontinued

Active Ingredient: DACLATASVIR DIHYDROCHLORIDE
Proprietary Name: DAKLINZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 90MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206843
Product Number: 003
Approval Date: Apr 13, 2016
Applicant Holder Full Name: BRISTOL-MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information