Application 213702

Type
NDA
Sponsor
PHARMA MAR USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEPZELCALURBINECTEDININJECTABLE;INJECTION4MGYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213702-001ZEPZELCALURBINECTEDIN4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-23
N213702-00177636152029-12-13U-4299Drug substance, Drug product2020-06-23
N213702-001123248062040-05-29U-42122025-07-07
N213702-001124338902040-05-29U-43052025-11-06
N213702-001124404902040-05-29U-42522025-11-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N213702-001ODE-3042027-06-15
N213702-001I-9772028-10-02

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-1584e616aacf4f…
2026-08-18 06:07:402026-07N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213702-001ZEPZELCA4MG/VIALPOWDER / INTRAVENOUSRLD, RS2020-06-15a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N213702-00177636152029-12-13U-4299Drug substance, Drug product2020-06-2384e616aacf4f…
2026-09-14 22:38:342026-08N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-2384e616aacf4f…
2026-09-14 22:38:342026-08N213702-001123248062040-05-29U-42122025-07-0784e616aacf4f…
2026-09-14 22:38:342026-08N213702-001124338902040-05-29U-43052025-11-0684e616aacf4f…
2026-09-14 22:38:342026-08N213702-001124404902040-05-29U-42522025-11-1384e616aacf4f…
2026-08-18 06:07:402026-07N213702-00177636152029-12-13U-4299Drug substance, Drug product2020-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213702-001123248062040-05-29U-42122025-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07N213702-001124338902040-05-29U-43052025-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07N213702-001124404902040-05-29U-42522025-11-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213702-00177636152029-12-13U-4299Drug substance, Drug product2020-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213702-001123248062040-05-29U-42122025-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213702-001124338902040-05-29U-43052025-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213702-001124404902040-05-29U-42522025-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213702-00177636152029-12-13U-4299Drug substance, Drug product2020-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213702-001123248062040-05-29U-42122025-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213702-001124338902040-05-29U-43052025-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213702-001124404902040-05-29U-42522025-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213702-001123248062040-05-29U-42122025-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N213702-00177636152029-12-13U-2836Drug substance, Drug product2020-06-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213702-00177636152024-12-13U-2836Drug substance, Drug product2020-06-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N213702-00177636152024-12-13U-2836Drug substance, Drug product2020-06-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N213702-00177636152024-12-13U-2836Drug substance, Drug product2020-06-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N213702-00177636152024-12-13U-2836Drug substance, Drug product2020-06-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N213702-00177636152024-12-13U-2836Drug substance, Drug product2020-06-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213702-00177636152024-12-13U-2836Drug substance, Drug product2020-06-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N213702-00177636152024-12-13U-2836Drug substance, Drug product2020-06-235aa47cf7b7d7…

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2021-12-28 21:50 UTC2021-12N213702-001NCE2025-06-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N213702-001ODE-3042027-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213702-001NCE2025-06-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213702-001ODE-3042027-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N213702-001NCE2025-06-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N213702-001ODE-3042027-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N213702-001NCE2025-06-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N213702-001ODE-3042027-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N213702-001NCE2025-06-15c0c555d07b60…
2020-11-12 02:37 UTC2020-11N213702-001ODE-3042027-06-15c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N213702-001NCE2025-06-156a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N213702-001ODE-3042027-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N213702-001NCE2025-06-151c564ffb4f44…
2024-02-18 07:12 UTC2024-02N213702-001ODE-3042027-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N213702-001NCE2025-06-15ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N213702-001ODE-3042027-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N213702-001NCE2025-06-15a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N213702-001ODE-3042027-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N213702-001NCE2025-06-159b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N213702-001ODE-3042027-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N213702-001NCE2025-06-15a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N213702-001ODE-3042027-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N213702-001NCE2025-06-153f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N213702-001ODE-3042027-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N213702-001NCE2025-06-15053a50430f4f…
2023-05-13 08:27 UTC2023-05N213702-001ODE-3042027-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N213702-001NCE2025-06-153bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N213702-001ODE-3042027-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N213702-001NCE2025-06-153a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N213702-001ODE-3042027-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N213702-001NCE2025-06-15f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N213702-001ODE-3042027-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N213702-001NCE2025-06-15e64feba35796…
2022-09-29 23:25 UTC2022-09N213702-001ODE-3042027-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N213702-001NCE2025-06-15cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N213702-001ODE-3042027-06-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213702-001ODE-3042027-06-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213702-001I-9772028-10-02a50c72e98297…

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68727-712ZEPZELCALurbinectedinJazz Pharmaceuticals, Inc.NDACurrent
68727-712ZEPZELCALurbinectedinJazz Pharmaceuticals, Inc.NDACurrent
68727-712ZEPZELCALurbinectedinJazz Pharmaceuticals, Inc.NDACurrent
68727-712ZEPZELCALurbinectedinJazz Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85277SUPPL 2026-03-06
85208SUPPL 2026-03-03
83655SUPPL 2025-10-03
83631SUPPL 2025-10-02
82148SUPPL 2025-05-05
82266SUPPL 2025-04-30
74955SUPPL 2023-07-31
74950SUPPL 2023-07-31
70688SUPPL2022-04-05
70685SUPPL2022-04-04
63896ORIG2020-07-14
63576ORIG2020-06-16
63570ORIG2020-06-15