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Drugs@FDA: FDA-Approved Drugs

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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CHLORIDE EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No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
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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