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Details for New Drug Application (NDA): 205390

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NDA 205390 describes VECURONIUM BROMIDE, which is a drug marketed by Sun Pharma Global, Eurohlth Intl Sarl, 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 eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the vecuronium bromide profile page.

Summary for NDA: 205390

Gland Pharma Ltd
vecuronium bromide

Pharmacology for NDA: 205390

Suppliers and Packaging for NDA: 205390

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vecuronium bromide
INJECTABLE;INJECTION 205390 ANDA Gland Pharma Limited 68083-139 68083-139-10 10 VIAL in 1 CARTON (68083-139-10) > 10 mL in 1 VIAL (68083-139-01)
vecuronium bromide
INJECTABLE;INJECTION 205390 ANDA Gland Pharma Limited 68083-140 68083-140-10 10 VIAL in 1 CARTON (68083-140-10) > 20 mL in 1 VIAL (68083-140-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/VIAL
Approval Date:May 26, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:May 26, 2016TE:APRLD:No

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