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Details for New Drug Application (NDA): 208624
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 nineteen 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.
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 208624
| Tradename: | VIEKIRA XR |
| Applicant: | Abbvie Inc |
| Ingredient: | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir |
| Patents: | 19 |
| 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 | N | 0074-0063-28 |
| VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624 | NDA | AbbVie Inc. | 0074-0063 | N | 0074-0063-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 200MG BASE;8.33MG;50MG;33.33MG | ||||
| Approval Date: | Jul 22, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 19, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jul 19, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Sign Up | Patent Expiration: | Nov 10, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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