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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209260

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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N209260
Product Number: 001
Approval Date: Jan 26, 2018
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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