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Details for New Drug Application (NDA): 204790

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NDA 204790 describes TIVICAY, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the TIVICAY profile page.

The generic ingredient in TIVICAY is dolutegravir sodium. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.

Summary for NDA: 204790

Tradename:
TIVICAY
Applicant:
Viiv Hlthcare
Ingredient:
dolutegravir sodium
Patents:2
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204790

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIVICAY
dolutegravir sodium
TABLET;ORAL 204790 NDA ViiV Healthcare Company 49702-226 49702-226-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-226-13)
TIVICAY
dolutegravir sodium
TABLET;ORAL 204790 NDA ViiV Healthcare Company 49702-227 49702-227-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 12, 2013TE:RLD:Yes
Patent:8,129,385Patent Expiration:Oct 5, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:9,242,986Patent Expiration:Dec 8, 2029Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Aug 12, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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