Application 202497

Type: NDA
Sponsor: ACROTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MARQIBO KIT	VINCRISTINE SULFATE	INJECTABLE, LIPOSOMAL;INTRAVENOUS	5MG/5ML (1MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N202497-001	MARQIBO KIT	VINCRISTINE SULFATE	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS		RLD	2012-08-09

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2012-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2012-08-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2012-08-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2012-08-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2012-08-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2012-08-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2012-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2012-08-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2012-08-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202497-001	MARQIBO KIT	5MG/5ML (1MG/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD	2012-08-09	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N202497-001	6723338	2020-03-31	U-1271		2012-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202497-001	7887836	2020-03-31	U-1271		2012-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202497-001	7247316	2020-09-25		Drug product	2012-09-06	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N202497-001	6723338	2020-03-31	U-1271		2012-09-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202497-001	7887836	2020-03-31	U-1271		2012-09-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202497-001	7247316	2020-09-25		Drug product	2012-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202497-001	6723338	2020-03-31	U-1271		2012-09-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202497-001	7887836	2020-03-31	U-1271		2012-09-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202497-001	7247316	2020-09-25		Drug product	2012-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202497-001	6723338	2020-03-31	U-1271		2012-09-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202497-001	7887836	2020-03-31	U-1271		2012-09-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202497-001	7247316	2020-09-25		Drug product	2012-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202497-001	6723338	2020-03-31	U-1271		2012-09-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202497-001	7887836	2020-03-31	U-1271		2012-09-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202497-001	7247316	2020-09-25		Drug product	2012-09-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202497-001	6723338	2020-03-31	U-1271		2012-09-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202497-001	7887836	2020-03-31	U-1271		2012-09-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202497-001	7247316	2020-09-25		Drug product	2012-09-06	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N202497-001	ODE-28	2019-08-09	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N202497-001	ODE-28	2019-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202497-001	ODE-28	2019-08-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202497-001	ODE-28	2019-08-09	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VinCRIStine Sulfate	VINCRISTINE SULFATE	Hospira, Inc.	b22e4c8e-dbe1-4d4b-a026-e1812974071c	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VINCRISTINE SULFATE
VinCRIStine Sulfate	VINCRISTINE SULFATE	Hospira, Inc.	49596de6-ab18-49d1-9e5b-30968fc21c36	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VINCRISTINE SULFATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
20536-322	Marqibo	Vincristine Sulfate	Talon Therapeutics, Inc.	NDA	Current
72893-008	Marqibo	Vincristine Sulfate	Acrotech Biopharma LLC	NDA	Current
72893-008	Marqibo	Vincristine Sulfate	Acrotech Biopharma LLC	NDA	Current
72893-008	Marqibo	Vincristine Sulfate	Acrotech Biopharma LLC	NDA	Current
72893-008	Marqibo	Vincristine Sulfate	Acrotech Biopharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70552	SUPPL	2022-03-17
70528	SUPPL	2022-03-16
63825	SUPPL	2020-07-08
63468	SUPPL	2020-06-09
63465	SUPPL	2020-06-09
61513	SUPPL	2020-01-06
44858	ORIG	2013-09-03
43404	ORIG	2013-09-03
32267	ORIG	2012-08-10
19353	ORIG	2012-08-09