Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205703

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ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER (ESMOLOL HYDROCHLORIDE)
2GM/100ML (20MG/ML) Marketing Status: Prescription

Active Ingredient: ESMOLOL HYDROCHLORIDE
Proprietary Name: ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2GM/100ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205703
Product Number: 002
Approval Date: Apr 7, 2016
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER (ESMOLOL HYDROCHLORIDE)
2.5GM/250ML (10MG/ML) Marketing Status: Prescription

Active Ingredient: ESMOLOL HYDROCHLORIDE
Proprietary Name: ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2.5GM/250ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205703
Product Number: 001
Approval Date: Apr 7, 2016
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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