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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216903

PREVDUO (GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE)
0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)
Marketing Status: Prescription
Active Ingredient: GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE
Proprietary Name: PREVDUO
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216903
Product Number: 001
Approval Date: Feb 23, 2023
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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