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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213581

ATROPINE SULFATE (ATROPINE SULFATE)
1%
Marketing Status: Prescription
Active Ingredient: ATROPINE SULFATE
Proprietary Name: ATROPINE SULFATE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213581
Product Number: 001
Approval Date: Mar 15, 2022
Applicant Holder Full Name: BAUSCH AND LOMB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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