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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020131

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NDA 020131 describes PROHANCE, which is a drug marketed by Bracco and is included in two NDAs. It is available from two suppliers. Additional details are available on the PROHANCE profile page.

The generic ingredient in PROHANCE is gadoteridol. Two suppliers are listed for this compound. Additional details are available on the gadoteridol profile page.

Summary for NDA: 020131

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

Pharmacology for NDA: 020131

Suppliers and Packaging for NDA: 020131

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROHANCE
gadoteridol
INJECTABLE;INJECTION 020131 NDA BRACCO DIAGNOSTICS INC 0270-1111 0270-1111-70 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
PROHANCE
gadoteridol
INJECTABLE;INJECTION 020131 NDA BRACCO DIAGNOSTICS INC 0270-1111 0270-1111-01 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength279.3MG/ML
Approval Date:Nov 16, 1992TE:RLD:Yes

Expired Orange Book Patents for NDA: 020131

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco
PROHANCE
gadoteridol
INJECTABLE;INJECTION020131-001Nov 16, 1992► Subscribe► Subscribe
Bracco
PROHANCE
gadoteridol
INJECTABLE;INJECTION020131-001Nov 16, 1992► Subscribe► Subscribe
Bracco
PROHANCE
gadoteridol
INJECTABLE;INJECTION020131-001Nov 16, 1992► Subscribe► Subscribe
Bracco
PROHANCE
gadoteridol
INJECTABLE;INJECTION020131-001Nov 16, 1992► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Accenture
US Department of Justice
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Chubb
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Dow

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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