Home Applications 213137 Application 213137
Type NDA
Sponsor GLOBAL BLOOD THERAPS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXBRYTA VOXELOTOR TABLET;ORAL 500MG Yes Yes 002 OXBRYTA VOXELOTOR TABLET;ORAL 300MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213137-001 OXBRYTA VOXELOTOR 500MG TABLET / ORAL RLD 2019-11-25 N213137-002 OXBRYTA VOXELOTOR 300MG TABLET / ORAL RLD 2022-10-14
Orange Book patents# Current patent rows page 1 of 1 · 26 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213137-001 10017491 2032-12-28 Drug product 2019-12-19 N213137-001 10034879 2032-12-28 Drug substance, Drug product 2019-12-19 N213137-001 10806733 2032-12-28 Drug substance 2020-11-19 N213137-001 9018210 2033-11-25 Drug substance, Drug product 2019-12-19 N213137-001 9248199 2034-01-29 U-2676 2019-12-19 N213137-001 9248199 2034-01-29 U-2715 2019-12-19 N213137-001 10722502 2035-02-06 Drug product 2020-08-27 N213137-001 11452720 2035-02-06 U-3459 2022-10-27 N213137-001 9447071 2035-02-06 Drug substance, Drug product 2019-12-19 N213137-001 11020382 2036-12-02 U-3133 2021-06-23 N213137-001 11020382 2036-12-02 U-3134 2021-06-23 N213137-001 11944612 2036-12-02 U-3893 2024-05-02 N213137-001 10493035 2037-10-12 Drug product 2019-12-19 N213137-002 10017491 2032-12-28 Drug product 2022-11-14 N213137-002 10034879 2032-12-28 Drug substance, Drug product 2022-11-14 N213137-002 10806733 2032-12-28 Drug substance 2022-11-14 N213137-002 9018210 2033-11-25 Drug substance, Drug product 2022-11-14 N213137-002 9248199 2034-01-29 U-2676 2022-11-14 N213137-002 9248199 2034-01-29 U-2715 2022-11-14 N213137-002 10722502 2035-02-06 Drug product 2022-11-14 N213137-002 11452720 2035-02-06 U-3459 2022-10-27 N213137-002 9447071 2035-02-06 Drug substance, Drug product 2022-11-14 N213137-002 11020382 2036-12-02 U-3133 2022-11-14 N213137-002 11020382 2036-12-02 U-3134 2022-11-14 N213137-002 11944612 2036-12-02 U-3893 2024-05-02 N213137-002 10493035 2037-10-12 Drug product 2022-11-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213137-001 ODE-281 2026-11-25 N213137-001 ODE-394 2028-12-17 N213137-002 ODE-394 2028-12-17
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 · 67 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 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD 2019-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213137-002 OXBRYTA 300MG TABLET / ORAL RLD 2022-10-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213137-001 OXBRYTA 500MG TABLET / ORAL RLD, RS 2019-11-25 8869cabd3fbd…
Observed Orange Book patent history# Patent history page 1 of 20 · 794 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N213137-001 10017491 2032-12-28 Drug product 2019-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 10034879 2032-12-28 Drug substance, Drug product 2019-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 10806733 2032-12-28 Drug substance 2020-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 9018210 2033-11-25 Drug substance, Drug product 2019-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 9248199 2034-01-29 U-2676 2019-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 9248199 2034-01-29 U-2715 2019-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 10722502 2035-02-06 Drug product 2020-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 11452720 2035-02-06 U-3459 2022-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 9447071 2035-02-06 Drug substance, Drug product 2019-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 11020382 2036-12-02 U-3133 2021-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 11020382 2036-12-02 U-3134 2021-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 11944612 2036-12-02 U-3893 2024-05-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-001 10493035 2037-10-12 Drug product 2019-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 10017491 2032-12-28 Drug product 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 10034879 2032-12-28 Drug substance, Drug product 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 10806733 2032-12-28 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 9018210 2033-11-25 Drug substance, Drug product 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 9248199 2034-01-29 U-2676 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 9248199 2034-01-29 U-2715 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 10722502 2035-02-06 Drug product 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 11452720 2035-02-06 U-3459 2022-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 9447071 2035-02-06 Drug substance, Drug product 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 11020382 2036-12-02 U-3133 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 11020382 2036-12-02 U-3134 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 11944612 2036-12-02 U-3893 2024-05-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213137-002 10493035 2037-10-12 Drug product 2022-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213137-001 10017491 2032-12-28 Drug product 2019-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 10034879 2032-12-28 Drug substance, Drug product 2019-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 10806733 2032-12-28 Drug substance 2020-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 9018210 2033-11-25 Drug substance, Drug product 2019-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 9248199 2034-01-29 U-2676 2019-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 9248199 2034-01-29 U-2715 2019-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 10722502 2035-02-06 Drug product 2020-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 11452720 2035-02-06 U-3459 2022-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 9447071 2035-02-06 Drug substance, Drug product 2019-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 11020382 2036-12-02 U-3133 2021-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 11020382 2036-12-02 U-3134 2021-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 11944612 2036-12-02 U-3893 2024-05-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-001 10493035 2037-10-12 Drug product 2019-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213137-002 10017491 2032-12-28 Drug product 2022-11-14 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 2 of 4 · 133 observed states.
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 OXBRYTA VOXELOTOR Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. 3c557fac-29ec-483f-b691-8a935d4decc3 2023-12-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 213137 application number: NDA213137 ndc (product): 72786-101 ndc (product): 72786-102
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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72786-101 OXBRYTA Voxelotor Global Blood Therapeutics Inc. NDA Current 72786-101 OXBRYTA Voxelotor Global Blood Therapeutics Inc. NDA Current 72786-101 OXBRYTA Voxelotor Global Blood Therapeutics Inc. NDA Current 72786-101 OXBRYTA Voxelotor Global Blood Therapeutics Inc. NDA Current 72786-101 OXBRYTA Voxelotor Global Blood Therapeutics Inc. NDA Current 72786-101 OXBRYTA Voxelotor Global Blood Therapeutics Inc. NDA Current 72786-101 OXBRYTA Voxelotor Global Blood Therapeutics Inc. NDA Current 72786-102 OXBRYTA Voxelotor Global Blood Therapeutics Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 75258 SUPPL 2023-08-22 75147 SUPPL 2023-08-21 69736 SUPPL 2021-12-22 69621 SUPPL 2021-12-17 61373 ORIG 2019-12-23 61062 ORIG 2019-11-26 61047 ORIG 2019-11-25