Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204300

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VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE)
10MG/ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: VAZCULEP
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP1
Application Number: N204300
Product Number: 001
Approval Date: Jun 27, 2014
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE)
50MG/5ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: VAZCULEP
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MG/5ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP1
Application Number: N204300
Product Number: 002
Approval Date: Jun 27, 2014
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE)
100MG/10ML (10MG/ML)
Marketing Status: Prescription

Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: VAZCULEP
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/10ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP1
Application Number: N204300
Product Number: 003
Approval Date: Jun 27, 2014
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information