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NORCURON

NDA

VECURONIUM BROMIDE | N018776 | ORGANON USA INC

2 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVVECURONIUM BROMIDE

DMF 99251992

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDVECURONIUM BROMIDE

DMF 120501996

CURIA ITALY SRLVECURONIUM BROMIDE

DMF 120631996

ASPEN OSS BVVECURONIUM BROMIDE

DMF 200592006

DIOSYNTH BVInactiveVECURONIUM BROMIDE

DMF 120021996

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 29, 2010	SUPPL -30	View Letter (PDF)
Jun 8, 2003	SUPPL -27	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 30, 1984

No patent or exclusivity listings for this strength.

#003 — 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 3, 1992