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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020098
Company: ABBVIE

Products on NDA 020098

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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MIVACURIUM CHLORIDE	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
MIVACRON	MIVACURIUM CHLORIDE	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
MIVACRON	MIVACURIUM CHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	EQ 0.5MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	EQ 50MG BASE/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020098

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/1992	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2018	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020098s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020098Orig1s019Ltr.pdf
01/30/2015	SUPPL-18	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020098s018lbl.pdf
11/22/2010	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020098s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020098s017ltr.pdf
10/15/2002	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/04/2002	SUPPL-13	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20098s013ltr.pdf
02/20/2001	SUPPL-12	Labeling		Label is not available on this site.
03/17/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/25/1999	SUPPL-10	Labeling		Label is not available on this site.
05/19/1998	SUPPL-9	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron.cfm
06/04/1997	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
06/09/1995	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/18/1994	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
01/25/1994	SUPPL-4	Labeling		Label is not available on this site.
04/15/1994	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/02/1994	SUPPL-2	Labeling		Label is not available on this site.
02/08/1995	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020098

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020098s019lbl.pdf
07/26/2018	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020098s019lbl.pdf
01/30/2015	SUPPL-18	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020098s018lbl.pdf
11/22/2010	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020098s017lbl.pdf
05/19/1998	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron_appltr_prntlbl.pdf

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