Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Baxter
Novartis
Chubb
McKesson
Argus Health
Chinese Patent Office
Cerilliant
Moodys
Deloitte
Federal Trade Commission

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078396

« Back to Dashboard

NDA 078396 describes EPOPROSTENOL SODIUM, which is a drug marketed by Teva Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the EPOPROSTENOL SODIUM profile page.

The generic ingredient in EPOPROSTENOL SODIUM 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 078396
Tradename:EPOPROSTENOL SODIUM
Applicant:Teva Pharms Usa
Ingredient:epoprostenol sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078396
Ingredient-typeProstaglandins I
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 078396
Suppliers and Packaging for NDA: 078396
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396 ANDA Teva Parenteral Medicines, Inc. 0703-1985 N 0703-1985-01
EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396 ANDA Teva Parenteral Medicines, Inc. 0703-1995 N 0703-1995-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/VIAL
Approval Date:Apr 23, 2008TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.5MG BASE/VIAL
Approval Date:Apr 23, 2008TE:APRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chubb
Queensland Health
Daiichi Sankyo
UBS
US Army
Baxter
Medtronic
Merck

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.

botpot