Home Applications 206353 Application 206353
Type NDA
Sponsor BRISTOL-MYERS SQUIBB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EVOTAZ ATAZANAVIR SULFATE; COBICISTAT TABLET;ORAL EQ 300MG BASE;150MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N206353-001 EVOTAZ ATAZANAVIR SULFATE; COBICISTAT EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 N206353-001 10039718 2032-10-06 Drug product 2018-09-05
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 2 · 41 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 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 86 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 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206353-001 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206353-001 10039718 2032-10-04 Drug product 2018-09-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 782e0a99824c…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EVOTAZ ATAZANAVIR AND COBICISTAT E.R. Squibb & Sons, L.L.C. 83db29d7-5d85-49d6-8cb6-740473365cf8 2025-05-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 206353 application number: NDA206353 ndc (product): 0003-3641
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0003-3641 EVOTAZ atazanavir and cobicistat E.R. Squibb & Sons, L.L.C. NDA Current 0003-3641 EVOTAZ atazanavir and cobicistat E.R. Squibb & Sons, L.L.C. NDA Current 0003-3641 EVOTAZ atazanavir and cobicistat E.R. Squibb & Sons, L.L.C. NDA Current 0003-3641 EVOTAZ atazanavir and cobicistat E.R. Squibb & Sons, L.L.C. NDA Current 0003-3641 EVOTAZ atazanavir and cobicistat E.R. Squibb & Sons, L.L.C. NDA Current 50090-1724 EVOTAZ atazanavir and cobicistat A-S Medication Solutions NDA Current