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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209510

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BARHEMSYS (AMISULPRIDE)
5MG/2ML (2.5MG/ML)
Marketing Status: Prescription
Active Ingredient: AMISULPRIDE
Proprietary Name: BARHEMSYS
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5MG/2ML (2.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209510
Product Number: 001
Approval Date: Feb 26, 2020
Applicant Holder Full Name: ACACIA PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
BARHEMSYS (AMISULPRIDE)
10MG/4ML (2.5MG/ML)
Marketing Status: Prescription
Active Ingredient: AMISULPRIDE
Proprietary Name: BARHEMSYS
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/4ML (2.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209510
Product Number: 002
Approval Date: Sep 1, 2020
Applicant Holder Full Name: ACACIA PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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