Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020098
Company: ABBVIE
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CHLORIDE EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No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
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-Container/Carton Labels, Labeling-Package Insert 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/26/2018 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020098s019lbl.pdf
07/26/2018 SUPPL-19 Labeling-Package Insert 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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