Details for New Drug Application (NDA): 020444
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The generic ingredient in FLOLAN is epoprostenol sodium. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
Summary for 020444
Tradename: | FLOLAN |
Applicant: | Glaxosmithkline Llc |
Ingredient: | epoprostenol sodium |
Patents: | 0 |
Pharmacology for NDA: 020444
Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 020444
Suppliers and Packaging for NDA: 020444
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444 | NDA | GlaxoSmithKline LLC | 0173-0517 | 0173-0517-00 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0517-00) |
FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444 | NDA | GlaxoSmithKline LLC | 0173-0519 | 0173-0519-00 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0519-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/VIAL | ||||
Approval Date: | Sep 20, 1995 | TE: | AP1 | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.5MG BASE/VIAL | ||||
Approval Date: | Sep 20, 1995 | TE: | AP1 | RLD: | Yes |
Expired US Patents for NDA 020444
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