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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 015193

MESTINON (PYRIDOSTIGMINE BROMIDE)
60MG/5ML
Marketing Status: Prescription
Active Ingredient: PYRIDOSTIGMINE BROMIDE
Proprietary Name: MESTINON
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 60MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N015193
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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