Application 020098

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIVACRON	MIVACURIUM CHLORIDE	SOLUTION;INTRAVENOUS	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	INJECTABLE;INJECTION	EQ 0.5MG BASE/ML	No	No
003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	INJECTABLE;INJECTION	EQ 50MG BASE/100ML	No	No
004	MIVACRON	MIVACURIUM CHLORIDE	SOLUTION;INTRAVENOUS	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	Yes	No
005	MIVACRON	MIVACURIUM CHLORIDE	SOLUTION;INTRAVENOUS	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020098-001	MIVACRON	MIVACURIUM CHLORIDE	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22
N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22
N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22
N020098-004	MIVACRON	MIVACURIUM CHLORIDE	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22
N020098-005	MIVACRON	MIVACURIUM CHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22

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 4 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2021-03-12 10:30 UTC	2021-03	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`1c564ffb4f44…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55044	SUPPL	2018-07-30
55026	SUPPL	2018-07-27
12210	SUPPL	2015-02-03
2016	SUPPL	2010-11-30
34260	SUPPL	2010-11-22
34259	SUPPL	2004-06-09
21148	SUPPL	2004-06-09
2015	SUPPL	2002-06-04
41143	SUPPL	2000-07-03