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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215624

Marketing Status: Prescription
Active Ingredient: ATROPINE SULFATE
Proprietary Name: ATROPINE SULFATE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 1%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A215624
Product Number: 001
Approval Date: Nov 26, 2021
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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