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EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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MIVACURIUM CHLORIDE	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22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 5 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
2023-12-20 04:57 UTC	2023-12	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`3a93d1ddd44b…`

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