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Generated: November 14, 2018

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Details for New Drug Application (NDA): 020444

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NDA 020444 describes FLOLAN, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. Additional details are available on the FLOLAN profile page.

The generic ingredient in FLOLAN is epoprostenol sodium. There are seven drug master file entries for this compound. Three 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020444
Ingredient-typeProstaglandins I
Physiological EffectVasodilation
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 0173-0518 0173-0518-01 2 VIAL in 1 TRAY (0173-0518-01) > 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/VIAL
Approval Date:Sep 20, 1995TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.5MG BASE/VIAL
Approval Date:Sep 20, 1995TE:APRLD:Yes

Expired US Patents for NDA 020444

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Medtronic
Queensland Health
Fish and Richardson
Moodys
McKesson
Chubb
Cipla
US Department of Justice

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