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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
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Daiichi Sankyo
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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065036

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NDA 065036 describes IDARUBICIN HYDROCHLORIDE PFS, 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 IDARUBICIN HYDROCHLORIDE PFS profile page.

The generic ingredient in IDARUBICIN HYDROCHLORIDE PFS is idarubicin hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.

Summary for NDA: 065036

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

Pharmacology for NDA: 065036

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 065036

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IDARUBICIN HYDROCHLORIDE PFS
idarubicin hydrochloride
INJECTABLE;INJECTION 065036 ANDA Teva Parenteral Medicines, Inc. 0703-4154 0703-4154-11 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-4154-11) > 5 mL in 1 VIAL, SINGLE-DOSE
IDARUBICIN HYDROCHLORIDE PFS
idarubicin hydrochloride
INJECTABLE;INJECTION 065036 ANDA Teva Parenteral Medicines, Inc. 0703-4155 0703-4155-11 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-4155-11) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:May 1, 2002TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
US Army
Chubb
Deloitte
McKesson
McKinsey
Merck
Medtronic
Fuji
Johnson and Johnson

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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