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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
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Generated: December 12, 2017

DrugPatentWatch Database Preview

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:1
Applicant:1
Ingredient:1
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

Summary for product number 001

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

Summary for product number 002

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

Expired Orange Book Patents for NDA: 020444

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-002Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-001Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-002Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-002Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-001Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-002Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-001Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-001Sep 20, 1995► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Citi
Deloitte
Merck
Fuji
Covington
Cipla
Dow
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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