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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020444

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FLOLAN (EPOPROSTENOL SODIUM)
EQ 0.5MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: EPOPROSTENOL SODIUM
Proprietary Name: FLOLAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.5MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP1
Application Number: N020444
Product Number: 001
Approval Date: Sep 20, 1995
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
FLOLAN (EPOPROSTENOL SODIUM)
EQ 1.5MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: EPOPROSTENOL SODIUM
Proprietary Name: FLOLAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1.5MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP1
Application Number: N020444
Product Number: 002
Approval Date: Sep 20, 1995
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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