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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 213424

ATROPINE SULFATE (ATROPINE SULFATE)
8MG/20ML (0.4MG/ML)
Marketing Status: Prescription
Active Ingredient: ATROPINE SULFATE
Proprietary Name: ATROPINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL
Strength: 8MG/20ML (0.4MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213424
Product Number: 001
Approval Date: Mar 19, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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