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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 089335

Marketing Status: Prescription
Active Ingredient: GLYCOPYRROLATE
Proprietary Name: GLYCOPYRROLATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.2MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A089335
Product Number: 001
Approval Date: Jul 23, 1986
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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