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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207107

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ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE)
1GM/100ML
Marketing Status: Prescription
Active Ingredient: ESMOLOL HYDROCHLORIDE
Proprietary Name: ESMOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207107
Product Number: 001
Approval Date: Jun 8, 2018
Applicant Holder Full Name: SAGENT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE)
2GM/100ML
Marketing Status: Prescription
Active Ingredient: ESMOLOL HYDROCHLORIDE
Proprietary Name: ESMOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207107
Product Number: 002
Approval Date: Jun 8, 2018
Applicant Holder Full Name: SAGENT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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