Home Applications 213687 Application 213687
Type NDA
Sponsor ULTRAGENYX PHARM INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOJOLVI TRIHEPTANOIN LIQUID;ORAL 35% Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N213687-001 DOJOLVI TRIHEPTANOIN 100% w/w LIQUID / ORAL RLD, RS 2020-06-30
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 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 N213687-001 12551461 2034-11-14 Drug product 2026-02-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213687-001 ODE-311 2027-06-30
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.
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 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 77 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 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213687-001 12551461 2034-11-14 Drug product 2026-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213687-001 12551461 2034-11-14 Drug product 2026-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213687-001 8697748 2025-10-03 Drug product 2020-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213687-001 8697748 2025-10-03 Drug product 2020-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213687-001 8697748 2025-10-03 Drug product 2020-10-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213687-001 8697748 2025-10-03 Drug product 2020-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 782e0a99824c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 74 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.
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69794-050 DOJOLVI Triheptanoin Ultragenyx Pharmaceutical Inc. NDA Current 69794-050 DOJOLVI Triheptanoin Ultragenyx Pharmaceutical Inc. NDA Current 69794-050 DOJOLVI Triheptanoin Ultragenyx Pharmaceutical Inc. NDA Current 69794-050 DOJOLVI Triheptanoin Ultragenyx Pharmaceutical Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76008 SUPPL 2023-10-31 75989 SUPPL 2023-10-31 64123 ORIG 2020-07-29 63772 ORIG 2020-07-01 63761 ORIG 2020-06-30