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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078396

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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 NDA: 078396

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078396

Ingredient-typeProstaglandins I
Physiological EffectVasodilation

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 0703-1985-01 1 VIAL in 1 CARTON (0703-1985-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
EPOPROSTENOL SODIUM
epoprostenol sodium
INJECTABLE;INJECTION 078396 ANDA Teva Parenteral Medicines, Inc. 0703-1995 0703-1995-01 1 VIAL in 1 CARTON (0703-1995-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Summary for product number 001

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

Summary for product number 002

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


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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Johnson and Johnson
Colorcon
Covington
Dow
Baxter
AstraZeneca
McKinsey
Fish and Richardson
Moodys

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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