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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211078

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PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
50MG/5ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: PHENYLEPHRINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MG/5ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP1
Application Number: A211078
Product Number: 001
Approval Date: Jul 19, 2018
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
100MG/10ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: PHENYLEPHRINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/10ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP1
Application Number: A211078
Product Number: 002
Approval Date: Jul 19, 2018
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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