Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204957

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ACETAMINOPHEN (ACETAMINOPHEN)
500MG/50ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN
Proprietary Name: ACETAMINOPHEN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 500MG/50ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204957
Product Number: 001
Approval Date: Feb 18, 2021
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ACETAMINOPHEN (ACETAMINOPHEN)
1GM/100ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN
Proprietary Name: ACETAMINOPHEN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/100ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204957
Product Number: 002
Approval Date: Feb 18, 2021
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information