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Last Updated: August 11, 2020

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Details for New Drug Application (NDA): 203725

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NDA 203725 describes VECURONIUM BROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Gland Pharma Ltd, Hikma, Hospira, Mylan Labs Ltd, Sagent Pharms Inc, Sun Pharm, Teva Pharms Usa, Watson Labs, and West-ward Pharms Int, and is included in twelve NDAs. It is available from nine suppliers. Additional details are available on the VECURONIUM BROMIDE profile page.

The generic ingredient in VECURONIUM BROMIDE is vecuronium bromide. There are six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the vecuronium bromide profile page.
Summary for 203725
Tradename:VECURONIUM BROMIDE
Applicant:Hikma
Ingredient:vecuronium bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203725
Medical Subject Heading (MeSH) Categories for 203725
Suppliers and Packaging for NDA: 203725
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VECURONIUM BROMIDE vecuronium bromide INJECTABLE;INJECTION 203725 ANDA Hikma Pharmaceuticals USA Inc. 0143-9232 0143-9232-10 10 VIAL in 1 CARTON (0143-9232-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9232-01)
VECURONIUM BROMIDE vecuronium bromide INJECTABLE;INJECTION 203725 ANDA Hikma Pharmaceuticals USA Inc. 0143-9234 0143-9234-10 10 VIAL in 1 CARTON (0143-9234-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9234-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/VIAL
Approval Date:Jul 30, 2019TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Jul 30, 2019TE:APRLD:No

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