Home Applications 206352 Application 206352
Type NDA
Sponsor BRISTOL MYERS SQUIBB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REYATAZ ATAZANAVIR SULFATE POWDER;ORAL EQ 50MG BASE/PACKET 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 N206352-001 REYATAZ ATAZANAVIR SULFATE EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02
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 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N206352-001 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N206352-001 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206352-001 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206352-001 6087383*PED 2019-06-21 Pediatric extension ea99ee380514…
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 N206352-001 PED 2019-03-24 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N206352-001 PED 2019-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206352-001 PED 2019-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206352-001 PED 2019-03-24 ea99ee380514…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0003-3638 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3638 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3638 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3638 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3638 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current