Home Applications 213702 Application 213702
Type NDA
Sponsor PHARMA MAR USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZEPZELCA LURBINECTEDIN INJECTABLE;INJECTION 4MG 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 N213702-001 ZEPZELCA LURBINECTEDIN 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 N213702-001 7763615 2029-12-13 U-4299 Drug substance, Drug product 2020-06-23 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 N213702-001 12433890 2040-05-29 U-4305 2025-11-06 N213702-001 12440490 2040-05-29 U-4252 2025-11-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213702-001 ODE-304 2027-06-15 N213702-001 I-977 2028-10-02
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.
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 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 60 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 N213702-001 7763615 2029-12-13 U-4299 Drug substance, Drug product 2020-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213702-001 12433890 2040-05-29 U-4305 2025-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213702-001 12440490 2040-05-29 U-4252 2025-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213702-001 7763615 2029-12-13 U-4299 Drug substance, Drug product 2020-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213702-001 12433890 2040-05-29 U-4305 2025-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213702-001 12440490 2040-05-29 U-4252 2025-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213702-001 7763615 2029-12-13 U-4299 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213702-001 12433890 2040-05-29 U-4305 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213702-001 12440490 2040-05-29 U-4252 2025-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 7763615 2029-12-13 U-4299 Drug substance, Drug product 2020-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 12433890 2040-05-29 U-4305 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 12440490 2040-05-29 U-4252 2025-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 5aa47cf7b7d7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 78 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 68727-712 ZEPZELCA Lurbinectedin Jazz Pharmaceuticals, Inc. NDA Current 68727-712 ZEPZELCA Lurbinectedin Jazz Pharmaceuticals, Inc. NDA Current 68727-712 ZEPZELCA Lurbinectedin Jazz Pharmaceuticals, Inc. NDA Current 68727-712 ZEPZELCA Lurbinectedin Jazz Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85277 SUPPL 2026-03-06 85208 SUPPL 2026-03-03 83655 SUPPL 2025-10-03 83631 SUPPL 2025-10-02 82148 SUPPL 2025-05-05 82266 SUPPL 2025-04-30 74955 SUPPL 2023-07-31 74950 SUPPL 2023-07-31 70688 SUPPL 2022-04-05 70685 SUPPL 2022-04-04 63896 ORIG 2020-07-14 63576 ORIG 2020-06-16 63570 ORIG 2020-06-15