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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078651

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ROCURONIUM BROMIDE (ROCURONIUM BROMIDE)
50MG/5ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: ROCURONIUM BROMIDE
Proprietary Name: ROCURONIUM BROMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/5ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A078651
Product Number: 001
Approval Date: Dec 29, 2008
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROCURONIUM BROMIDE (ROCURONIUM BROMIDE)
100MG/10ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: ROCURONIUM BROMIDE
Proprietary Name: ROCURONIUM BROMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/10ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A078651
Product Number: 002
Approval Date: Dec 29, 2008
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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