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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214919

GLYCOPYRROLATE (GLYCOPYRROLATE)
0.6MG/3ML (0.2MG/ML)
Marketing Status: Prescription
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: GLYCOPYRROLATE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS
Strength: 0.6MG/3ML (0.2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214919
Product Number: 001
Approval Date: Apr 21, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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