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Generated: May 23, 2017

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Details for New Drug Application (NDA): 090243

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NDA 090243 describes VECURONIUM BROMIDE, which is a drug marketed by Sun Pharma Global, West-ward Pharms Int, Watson Labs, Mylan Labs Ltd, Hospira, Sagent Pharms, Teva Pharms Usa, and Gland Pharma Ltd, and is included in ten NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the vecuronium bromide profile page.

Summary for NDA: 090243

Formulation / Manufacturing:see details

Pharmacology for NDA: 090243

Suppliers and Packaging for NDA: 090243

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vecuronium bromide
INJECTABLE;INJECTION 090243 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0094 0069-0094-02 10 VIAL in 1 CARTON (0069-0094-02) > 1 mL in 1 VIAL (0069-0094-01)
vecuronium bromide
INJECTABLE;INJECTION 090243 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0108 0069-0108-05 10 VIAL in 1 CARTON (0069-0108-05) > 1 mL in 1 VIAL (0069-0108-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/VIAL
Approval Date:May 11, 2010TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:May 11, 2010TE:APRLD:No

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