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MIVACRON

NDA

MIVACURIUM CHLORIDE | N020098 | ABBVIE INC

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Regulus Pharmaceutical Consulting, Inc FDA-2006-P-0202 Regulus Pharmaceutical Consulting, Inc. filed this petition on October 25, 2006, requesting that the FDA determine whether Mivacron (mivacurium chloride injection) 2 mg base/mL, held under NDA 20-098 by Abbott Laboratories, was withdrawn for safety or effectiveness reasons, and if not, to accept an	505(q)	2008-12-09	Open	Regulus Pharmaceutical Consulting

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

FARMABIOS SPAMIVACURIUM CHLORIDE

DMF 202322007

UNION QUIMICO FARMACEUTICA SAMIVACURIUM CHLORIDE

DMF 284152014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 30, 2018	SUPPL -19	View Letter (PDF)
Nov 30, 2010	SUPPL -17	View Letter (PDF)
Jun 9, 2004	SUPPL -9	View Letter (PDF)
Jun 4, 2002	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jan 22, 1992

No patent or exclusivity listings for this strength.

#004 — EQ 10MG BASE/5ML (EQ 2MG BASE/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jan 22, 1992

#005 — EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jan 22, 1992

#002 — EQ 0.5MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 22, 1992

#003 — EQ 50MG BASE/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 22, 1992