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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203826

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IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE)
0.5MG/5ML (0.1MG/ML)
Marketing Status: Prescription
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: IMMPHENTIV
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.5MG/5ML (0.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203826
Product Number: 004
Approval Date: Mar 9, 2023
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE)
1MG/10ML (0.1MG/ML)
Marketing Status: Prescription
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: IMMPHENTIV
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1MG/10ML (0.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203826
Product Number: 005
Approval Date: Mar 9, 2023
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
10MG/ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: PHENYLEPHRINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP2
Application Number: N203826
Product Number: 001
Approval Date: Dec 20, 2012
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203826
Product Number: 002
Approval Date: Jun 19, 2019
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
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: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203826
Product Number: 003
Approval Date: Jun 19, 2019
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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