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Details for New Drug Application (NDA): 208624

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NDA 208624 describes VIEKIRA XR, which is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug. Additional details are available on the VIEKIRA XR profile page.

The generic ingredient in VIEKIRA XR is dasabuvir sodium; ombitasvir; paritaprevir; ritonavir. One supplier is listed for this compound. Additional details are available on the dasabuvir sodium; ombitasvir; paritaprevir; ritonavir profile page.

Summary for NDA: 208624

Tradename:
VIEKIRA XR
Applicant:
Abbvie Inc
Ingredient:
dasabuvir sodium; ombitasvir; paritaprevir; ritonavir
Patents:18
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 208624

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIEKIRA XR
dasabuvir sodium; ombitasvir; paritaprevir; ritonavir
TABLET, EXTENDED RELEASE;ORAL 208624 NDA AbbVie Inc. 0074-0063 0074-0063-01 1 DOSE PACK in 1 CARTON (0074-0063-01) > 1 KIT in 1 DOSE PACK
VIEKIRA XR
dasabuvir sodium; ombitasvir; paritaprevir; ritonavir
TABLET, EXTENDED RELEASE;ORAL 208624 NDA AbbVie Inc. 0074-0063 0074-0063-28 4 CARTON in 1 CARTON (0074-0063-28) > 7 DOSE PACK in 1 CARTON > 1 KIT in 1 DOSE PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG BASE;8.33MG;50MG;33.33MG
Approval Date:Jul 22, 2016TE:RLD:Yes
Patent:7,148,359Patent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:7,364,752Patent Expiration:Nov 10, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:8,268,349Patent Expiration:Aug 25, 2024Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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