Home Applications 021567 Application 021567
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ATAZANAVIR SULFATE CAPSULE;ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 REYATAZ ATAZANAVIR SULFATE CAPSULE;ORAL EQ 150MG BASE Yes No 003 REYATAZ ATAZANAVIR SULFATE CAPSULE;ORAL EQ 200MG BASE Yes No 004 REYATAZ ATAZANAVIR SULFATE CAPSULE;ORAL EQ 300MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021567-001 REYATAZ ATAZANAVIR SULFATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 N021567-002 REYATAZ ATAZANAVIR SULFATE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 N021567-003 REYATAZ ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 N021567-004 REYATAZ ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 5 · 172 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 2026-09-14 22:38:34 2026-08 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 98 observed states.
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 N021567-001 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021567-002 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021567-003 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021567-004 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021567-001 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021567-002 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021567-003 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021567-004 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021567-001 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021567-002 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021567-003 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021567-004 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021567-001 6087383*PED 2019-06-21 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021567-002 6087383*PED 2019-06-21 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021567-003 6087383*PED 2019-06-21 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021567-004 6087383*PED 2019-06-21 Pediatric extension 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.
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 · 32 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0003-3622 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3622 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3622 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3622 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3622 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3624 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3624 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3624 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3624 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3624 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3631 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3631 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3631 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3631 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 0003-3631 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. NDA Current 50090-1007 REYATAZ ATAZANAVIR A-S Medication Solutions NDA Current 50090-1581 REYATAZ ATAZANAVIR A-S Medication Solutions NDA Current 59762-0408 ATAZANAVIR ATAZANAVIR Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-0409 ATAZANAVIR ATAZANAVIR Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-0410 ATAZANAVIR ATAZANAVIR Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-0410 ATAZANAVIR ATAZANAVIR Greenstone LLC NDA AUTHORIZED GENERIC Current 67296-1236 REYATAZ REYATAZ RedPharm Drug, Inc. NDA Current 67296-1236 REYATAZ REYATAZ RedPharm Drug, Inc. NDA Current 67296-1236 REYATAZ REYATAZ RedPharm Drug, Inc. NDA Current 69189-3624 REYATAZ ATAZANAVIR Avera McKennan Hospital NDA Current 69189-3631 REYATAZ ATAZANAVIR Avera McKennan Hospital NDA Current 70518-0469 REYATAZ ATAZANAVIR REMEDYREPACK INC. NDA Current 70518-0469 REYATAZ ATAZANAVIR REMEDYREPACK INC. NDA Current 70518-0688 REYATAZ ATAZANAVIR REMEDYREPACK INC. NDA Current 70518-0688 REYATAZ ATAZANAVIR REMEDYREPACK INC. NDA Current 70518-0725 REYATAZ ATAZANAVIR REMEDYREPACK INC. NDA Current 70518-0725 REYATAZ ATAZANAVIR REMEDYREPACK INC. NDA Current