Home Applications 206843 Application 206843
Type NDA
Sponsor BRISTOL-MYERS SQUIBB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DAKLINZA DACLATASVIR DIHYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Yes No 002 DAKLINZA DACLATASVIR DIHYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Yes No 003 DAKLINZA DACLATASVIR DIHYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206843-001 DAKLINZA DACLATASVIR DIHYDROCHLORIDE EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 N206843-002 DAKLINZA DACLATASVIR DIHYDROCHLORIDE EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 N206843-003 DAKLINZA DACLATASVIR DIHYDROCHLORIDE EQ 90MG BASE TABLET / ORAL RLD 2016-04-13
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 N206843-001 8900566 2027-08-08 U-1724 2015-08-21 N206843-001 8900566 2027-08-08 U-1725 2015-08-21 N206843-001 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 N206843-001 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 N206843-001 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 N206843-001 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 N206843-001 8329159 2029-07-24 Drug substance 2015-08-21 N206843-001 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 N206843-002 8900566 2027-08-08 U-1724 2015-08-21 N206843-002 8900566 2027-08-08 U-1725 2015-08-21 N206843-002 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 N206843-002 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 N206843-002 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 N206843-002 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 N206843-002 8329159 2029-07-24 Drug substance 2015-08-21 N206843-002 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 N206843-003 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 N206843-003 9421192 2027-08-08 U-1725 Drug substance 2016-09-21
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 1 of 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 19 · 738 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206843-001 8900566 2027-08-08 U-1725 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8900566 2027-08-08 U-1724 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8329159 2029-07-24 Drug substance 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8900566 2027-08-08 U-1725 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8900566 2027-08-08 U-1724 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8329159 2029-07-24 Drug substance 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-003 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-003 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 8900566 2027-08-08 U-1725 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 8900566 2027-08-08 U-1724 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 8329159 2029-07-24 Drug substance 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 8900566 2027-08-08 U-1725 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 8900566 2027-08-08 U-1724 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 8329159 2029-07-24 Drug substance 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-003 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-003 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206843-001 8900566 2027-08-08 U-1725 2015-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206843-001 8900566 2027-08-08 U-1724 2015-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206843-001 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206843-001 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 44 observed states.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0003-0011 DAKLINZA daclatasvir E.R. Squibb & Sons, L.L.C. NDA Current 0003-0011 DAKLINZA daclatasvir E.R. Squibb & Sons, L.L.C. NDA Current 0003-0213 DAKLINZA daclatasvir E.R. Squibb & Sons, L.L.C. NDA Current 0003-0213 DAKLINZA daclatasvir E.R. Squibb & Sons, L.L.C. NDA Current 0003-0213 DAKLINZA daclatasvir E.R. Squibb & Sons, L.L.C. NDA Current 0003-0215 DAKLINZA daclatasvir E.R. Squibb & Sons, L.L.C. NDA Current 0003-0215 DAKLINZA daclatasvir E.R. Squibb & Sons, L.L.C. NDA Current 0003-0215 DAKLINZA daclatasvir E.R. Squibb & Sons, L.L.C. NDA Current