Home Applications 208624 Application 208624
Type NDA
Sponsor ABBVIE INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VIEKIRA XR DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE;8.33MG;50MG;33.33MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208624-001 VIEKIRA XR DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2016-07-22
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208624-001 8501238 2028-09-17 U-1636 Drug substance, Drug product 2016-08-17 N208624-001 9139536 2028-11-09 U-1753 2016-08-17 N208624-001 8188104 2029-05-17 U-1636 Drug substance, Drug product 2016-08-17 N208624-001 8642538 2029-09-10 U-1638 Drug substance, Drug product 2016-08-17 N208624-001 9006387 2030-06-10 U-1687 2016-08-17 N208624-001 8420596 2031-04-10 Drug substance, Drug product 2016-08-17 N208624-001 9044480 2031-04-10 U-1638 2016-08-17 N208624-001 8686026 2031-06-09 Drug product 2016-08-17 N208624-001 8691938 2032-04-13 Drug substance, Drug product 2016-08-17 N208624-001 10201541 2032-05-17 Drug product 2019-03-14 N208624-001 10201584 2032-05-17 U-1889 2019-03-14 N208624-001 8466159 2032-09-04 U-1637 2016-08-17 N208624-001 8492386 2032-09-04 U-1840 2016-08-17 N208624-001 8680106 2032-09-04 U-1637 2016-08-17 N208624-001 8685984 2032-09-04 U-1840 2016-08-17 N208624-001 10105365 2035-01-02 U-1889 Drug product 2018-11-20 N208624-001 9333204 2035-01-02 U-1889 Drug product 2016-08-17 N208624-001 9744170 2035-01-02 U-1889 Drug product 2017-09-27
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N208624-001 VIEKIRA XR EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2016-07-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208624-001 VIEKIRA XR EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2016-07-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208624-001 VIEKIRA XR EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2016-07-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208624-001 VIEKIRA XR EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2016-07-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 22 · 872 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N208624-001 8501238 2028-09-17 U-1636 Drug substance, Drug product 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 9139536 2028-11-09 U-1753 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 8188104 2029-05-17 U-1636 Drug substance, Drug product 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 8642538 2029-09-10 U-1638 Drug substance, Drug product 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 9006387 2030-06-10 U-1687 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 8420596 2031-04-10 Drug substance, Drug product 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 9044480 2031-04-10 U-1638 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 8686026 2031-06-09 Drug product 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 8691938 2032-04-13 Drug substance, Drug product 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 10201541 2032-05-17 Drug product 2019-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 10201584 2032-05-17 U-1889 2019-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 8466159 2032-09-04 U-1637 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 8492386 2032-09-04 U-1840 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 8680106 2032-09-04 U-1637 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 8685984 2032-09-04 U-1840 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 10105365 2035-01-02 U-1889 Drug product 2018-11-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 9333204 2035-01-02 U-1889 Drug product 2016-08-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208624-001 9744170 2035-01-02 U-1889 Drug product 2017-09-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N208624-001 8501238 2028-09-17 U-1636 Drug substance, Drug product 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 9139536 2028-11-09 U-1753 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 8188104 2029-05-17 U-1636 Drug substance, Drug product 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 8642538 2029-09-10 U-1638 Drug substance, Drug product 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 9006387 2030-06-10 U-1687 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 8420596 2031-04-10 Drug substance, Drug product 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 9044480 2031-04-10 U-1638 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 8686026 2031-06-09 Drug product 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 8691938 2032-04-13 Drug substance, Drug product 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 10201541 2032-05-17 Drug product 2019-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 10201584 2032-05-17 U-1889 2019-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 8466159 2032-09-04 U-1637 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 8492386 2032-09-04 U-1840 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 8680106 2032-09-04 U-1637 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 8685984 2032-09-04 U-1840 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 10105365 2035-01-02 U-1889 Drug product 2018-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 9333204 2035-01-02 U-1889 Drug product 2016-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208624-001 9744170 2035-01-02 U-1889 Drug product 2017-09-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208624-001 8501238 2028-09-17 U-1636 Drug substance, Drug product 2016-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208624-001 9139536 2028-11-09 U-1753 2016-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208624-001 8188104 2029-05-17 U-1636 Drug substance, Drug product 2016-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208624-001 8642538 2029-09-10 U-1638 Drug substance, Drug product 2016-08-17 caaa826d4ba7…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N208624-001 NCE 2019-12-19 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N208624-001 NCE 2019-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208624-001 NCE 2019-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208624-001 NCE 2019-12-19 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0074-0063 Viekira Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir AbbVie Inc. NDA Current 0074-0063 Viekira Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir AbbVie Inc. NDA Current 0074-0063 Viekira Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir AbbVie Inc. NDA Current