Application 206843

Type
NDA
Sponsor
BRISTOL-MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAKLINZADACLATASVIR DIHYDROCHLORIDETABLET;ORALEQ 30MG BASEYesNo
002DAKLINZADACLATASVIR DIHYDROCHLORIDETABLET;ORALEQ 60MG BASEYesNo
003DAKLINZADACLATASVIR DIHYDROCHLORIDETABLET;ORALEQ 90MG BASEYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206843-001DAKLINZADACLATASVIR DIHYDROCHLORIDEEQ 30MG BASETABLET / ORALRLD2015-07-24
N206843-002DAKLINZADACLATASVIR DIHYDROCHLORIDEEQ 60MG BASETABLET / ORALRLD2015-07-24
N206843-003DAKLINZADACLATASVIR DIHYDROCHLORIDEEQ 90MG BASETABLET / ORALRLD2016-04-13

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206843-00189005662027-08-08U-17242015-08-21
N206843-00189005662027-08-08U-17252015-08-21
N206843-00194211922027-08-08U-1724Drug substance2016-09-21
N206843-00194211922027-08-08U-1725Drug substance2016-09-21
N206843-00186420252027-08-11U-1724Drug substance, Drug product2015-08-21
N206843-00186420252027-08-11U-1725Drug substance, Drug product2015-08-21
N206843-00183291592029-07-24Drug substance2015-08-21
N206843-00186291712031-06-13U-1724Drug substance, Drug product2015-08-21
N206843-00289005662027-08-08U-17242015-08-21
N206843-00289005662027-08-08U-17252015-08-21
N206843-00294211922027-08-08U-1724Drug substance2016-09-21
N206843-00294211922027-08-08U-1725Drug substance2016-09-21
N206843-00286420252027-08-11U-1724Drug substance, Drug product2015-08-21
N206843-00286420252027-08-11U-1725Drug substance, Drug product2015-08-21
N206843-00283291592029-07-24Drug substance2015-08-21
N206843-00286291712031-06-13U-1724Drug substance, Drug product2015-08-21
N206843-00394211922027-08-08U-1724Drug substance2016-09-21
N206843-00394211922027-08-08U-1725Drug substance2016-09-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206843-002DAKLINZAEQ 60MG BASETABLET / ORALRLD2015-07-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206843-003DAKLINZAEQ 90MG BASETABLET / ORALRLD2016-04-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206843-001DAKLINZAEQ 30MG BASETABLET / ORALRLD2015-07-248072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 19 · 738 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206843-00189005662027-08-08U-17252015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00189005662027-08-08U-17242015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00194211922027-08-08U-1725Drug substance2016-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00194211922027-08-08U-1724Drug substance2016-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00186420252027-08-11U-1724Drug substance, Drug product2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00186420252027-08-11U-1725Drug substance, Drug product2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00183291592029-07-24Drug substance2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00186291712031-06-13U-1724Drug substance, Drug product2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00289005662027-08-08U-17252015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00289005662027-08-08U-17242015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00294211922027-08-08U-1725Drug substance2016-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00294211922027-08-08U-1724Drug substance2016-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00286420252027-08-11U-1724Drug substance, Drug product2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00286420252027-08-11U-1725Drug substance, Drug product2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00283291592029-07-24Drug substance2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00286291712031-06-13U-1724Drug substance, Drug product2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00394211922027-08-08U-1725Drug substance2016-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206843-00394211922027-08-08U-1724Drug substance2016-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00189005662027-08-08U-17252015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00189005662027-08-08U-17242015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00194211922027-08-08U-1725Drug substance2016-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00194211922027-08-08U-1724Drug substance2016-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00186420252027-08-11U-1724Drug substance, Drug product2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00186420252027-08-11U-1725Drug substance, Drug product2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00183291592029-07-24Drug substance2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00186291712031-06-13U-1724Drug substance, Drug product2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00289005662027-08-08U-17252015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00289005662027-08-08U-17242015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00294211922027-08-08U-1725Drug substance2016-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00294211922027-08-08U-1724Drug substance2016-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00286420252027-08-11U-1724Drug substance, Drug product2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00286420252027-08-11U-1725Drug substance, Drug product2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00283291592029-07-24Drug substance2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00286291712031-06-13U-1724Drug substance, Drug product2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00394211922027-08-08U-1725Drug substance2016-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206843-00394211922027-08-08U-1724Drug substance2016-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N206843-00189005662027-08-08U-17252015-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206843-00189005662027-08-08U-17242015-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206843-00194211922027-08-08U-1725Drug substance2016-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206843-00194211922027-08-08U-1724Drug substance2016-09-216a471c1ec25d…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N206843-001D-1612019-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206843-001D-1622019-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206843-001I-7262019-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206843-001I-7272019-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206843-001NCE2020-07-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206843-002D-1612019-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206843-002D-1622019-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206843-002I-7262019-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206843-002I-7272019-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206843-002NCE2020-07-2474a2ff9319b5…
2020-12-22 03:56 UTC2020-12N206843-001NCE2020-07-248869cabd3fbd…
2020-12-22 03:56 UTC2020-12N206843-002NCE2020-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206843-001NCE2020-07-24c0c555d07b60…
2020-11-12 02:37 UTC2020-11N206843-002NCE2020-07-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206843-001D-1612019-02-053f01610625f2…
2019-12-14 00:12 UTC2019-12N206843-001D-1622019-02-053f01610625f2…
2019-12-14 00:12 UTC2019-12N206843-001I-7262019-02-053f01610625f2…
2019-12-14 00:12 UTC2019-12N206843-001I-7272019-02-053f01610625f2…
2019-12-14 00:12 UTC2019-12N206843-001NCE2020-07-243f01610625f2…
2019-12-14 00:12 UTC2019-12N206843-002D-1612019-02-053f01610625f2…
2019-12-14 00:12 UTC2019-12N206843-002D-1622019-02-053f01610625f2…
2019-12-14 00:12 UTC2019-12N206843-002I-7262019-02-053f01610625f2…
2019-12-14 00:12 UTC2019-12N206843-002I-7272019-02-053f01610625f2…
2019-12-14 00:12 UTC2019-12N206843-002NCE2020-07-243f01610625f2…
2019-09-15 20:21 UTC2019-09N206843-001D-1612019-02-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N206843-001D-1622019-02-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N206843-001I-7262019-02-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N206843-001I-7272019-02-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N206843-001NCE2020-07-24b00525d2431f…
2019-09-15 20:21 UTC2019-09N206843-002D-1612019-02-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N206843-002D-1622019-02-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N206843-002I-7262019-02-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N206843-002I-7272019-02-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N206843-002NCE2020-07-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N206843-001D-1612019-02-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N206843-001D-1622019-02-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N206843-001I-7262019-02-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N206843-001I-7272019-02-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N206843-001NCE2020-07-24ea99ee380514…
2019-07-19 19:46 UTC2019-07N206843-002D-1612019-02-05ea99ee380514…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-0011DAKLINZAdaclatasvirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0011DAKLINZAdaclatasvirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0213DAKLINZAdaclatasvirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0213DAKLINZAdaclatasvirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0213DAKLINZAdaclatasvirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0215DAKLINZAdaclatasvirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0215DAKLINZAdaclatasvirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0215DAKLINZAdaclatasvirE.R. Squibb & Sons, L.L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60580SUPPL2019-10-17
60574SUPPL2019-10-17
50400SUPPL2017-11-14
50381SUPPL2017-11-13
47250SUPPL2017-02-16
47221SUPPL2017-02-15
45165SUPPL2016-08-24
45164SUPPL2016-08-24
19739SUPPL2016-04-14
44952SUPPL2016-03-03
44951SUPPL2016-03-03
40569SUPPL2016-02-25
40568SUPPL2016-02-25
19738SUPPL2016-02-25
32830SUPPL2016-02-09
10601SUPPL2016-02-09
10600SUPPL2016-02-09
23027ORIG2015-08-28
19737ORIG2015-07-30
10599ORIG2015-07-28