Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210025

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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: A210025
Product Number: 002
Approval Date: Dec 21, 2018
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
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: A210025
Product Number: 003
Approval Date: Dec 21, 2018
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
10MG/ML (10MG/ML)
Marketing Status: Discontinued

Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: PHENYLEPHRINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210025
Product Number: 001
Approval Date: Dec 21, 2018
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information