Application 022025

Type: NDA
Sponsor: CLINIGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOTECT	DEXRAZOXANE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022025-001	TOTECT	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2007-09-06

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-09-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-09-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-09-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-09-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022025-001	TOTECT	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-09-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022025-001	TOTECT	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2007-09-06	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022025-001	6727253	2020-03-13	U-829	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022025-001	6727253	2020-03-13	U-829	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022025-001	6727253	2020-03-13	U-829	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022025-001	6727253	2020-03-13	U-829	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022025-001	6727253	2020-03-13	U-829	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022025-001	6727253	2020-03-13	U-829	`ea99ee380514…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66220-110	Totect	dexrazoxane hydrochloride	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-110	Totect	dexrazoxane hydrochloride	Cumberland Pharmaceuticals Inc.	NDA	Current
76310-110	Totect	dexrazoxane hydrochloride	CLINIGEN GROUP PLC	NDA	Current
76310-110	Totect	dexrazoxane hydrochloride	CLINIGEN GROUP PLC	NDA	Current
76310-110	Totect	dexrazoxane hydrochloride	CLINIGEN GROUP PLC	NDA	Current
76310-110	Totect	dexrazoxane hydrochloride	CLINIGEN GROUP PLC	NDA	Current
76310-110	Totect	dexrazoxane hydrochloride	Clinigen Limited	NDA	Current
76310-110	Totect	dexrazoxane hydrochloride	CLINIGEN GROUP PLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65134	SUPPL	2020-11-03
65127	SUPPL	2020-11-03
56526	SUPPL	2018-11-20
56504	SUPPL	2018-11-16
52543	SUPPL	2018-02-09
52523	SUPPL	2018-02-09
49057	SUPPL	2017-07-25
29101	SUPPL	2013-04-30
38103	SUPPL	2013-04-29
29100	SUPPL	2011-03-10
44665	ORIG	2009-11-24
42390	ORIG	2009-11-24
29099	SUPPL	2009-11-10
16792	SUPPL	2009-09-21
6714	SUPPL	2009-02-18
38102	SUPPL	2009-02-12
29098	ORIG	2007-09-11
16791	ORIG	2007-09-10