Home Applications 210730 Application 210730
Type NDA
Sponsor TREVENA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OLINVYK OLICERIDINE INJECTABLE;INTRAVENOUS 1.5MG No No 002 OLINVYK OLICERIDINE SOLUTION;INTRAVENOUS 2MG/2ML (1MG/ML) Yes Yes 003 OLINVYK OLICERIDINE SOLUTION;INTRAVENOUS 30MG/30ML (1MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210730-001 OLINVYK OLICERIDINE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 N210730-002 OLINVYK OLICERIDINE 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 N210730-003 OLINVYK OLICERIDINE 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210730-001 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 N210730-001 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 N210730-001 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 N210730-001 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 N210730-001 9642842 2032-03-23 U-2986 Drug product 2020-11-20 N210730-002 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 N210730-002 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 N210730-002 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 N210730-002 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 N210730-002 9642842 2032-03-23 U-2986 Drug product 2020-11-20 N210730-003 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 N210730-003 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 N210730-003 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 N210730-003 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 N210730-003 9642842 2032-03-23 U-2986 Drug product 2020-11-20
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 3 · 114 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 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210730-002 OLINVYK 2MG/2ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210730-003 OLINVYK 30MG/30ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210730-001 OLINVYK 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-30 301d65b070ca…
Observed Orange Book patent history# Patent history page 1 of 13 · 498 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 N210730-001 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-001 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-001 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-001 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-001 9642842 2032-03-23 U-2986 Drug product 2020-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-002 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-002 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-002 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-002 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-002 9642842 2032-03-23 U-2986 Drug product 2020-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-003 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-003 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-003 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-003 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210730-003 9642842 2032-03-23 U-2986 Drug product 2020-11-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210730-001 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-001 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-001 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-001 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-001 9642842 2032-03-23 U-2986 Drug product 2020-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-002 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-002 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-002 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-002 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-002 9642842 2032-03-23 U-2986 Drug product 2020-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-003 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-003 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-003 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-003 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210730-003 9642842 2032-03-23 U-2986 Drug product 2020-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210730-001 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-001 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-001 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-001 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-001 9642842 2032-03-23 U-2986 Drug product 2020-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-002 11077098 2032-03-23 U-2986 Drug substance, Drug product 2021-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-002 11931350 2032-03-23 U-2986 Drug substance 2024-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-002 8835488 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-002 9309234 2032-03-23 U-2986 Drug substance, Drug product 2020-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210730-002 9642842 2032-03-23 U-2986 Drug product 2020-11-20 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 3 of 3 · 99 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71308-011 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-011 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-011 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-011 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-021 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-021 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-021 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-021 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-301 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-301 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-301 OLINVYK OLICERIDINE Trevena, Inc. NDA Current 71308-301 OLINVYK OLICERIDINE Trevena, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84654 SUPPL 2026-01-06 84540 SUPPL 2025-12-23 77060 SUPPL 2023-12-19 76971 SUPPL 2023-12-18 68935 ORIG 2021-10-08 66545 SUPPL 2021-03-05 66543 SUPPL 2021-03-05 64493 ORIG 2020-09-04 64247 ORIG 2020-08-10 64245 ORIG 2020-08-10