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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 010040

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NDA 010040 describes CYSTOGRAFIN DILUTE, which is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTOGRAFIN DILUTE profile page.

The generic ingredient in CYSTOGRAFIN DILUTE is diatrizoate meglumine. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diatrizoate meglumine profile page.

Summary for NDA: 010040

Tradename:
10
Applicant:
1
Ingredient:
2
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 010040

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 010040

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIATRIZOATE MEGLUMINE
diatrizoate meglumine
INJECTABLE;INJECTION 010040 NDA BRACCO DIAGNOSTICS INC 0270-0149 0270-0149-57 10 BOTTLE in 1 PACKAGE (0270-0149-57) > 300 mL in 1 BOTTLE
RENO-60
diatrizoate meglumine
INJECTABLE;INJECTION 010040 NDA BRACCO DIAGNOSTICS INC 0270-0149 0270-0149-57 10 BOTTLE in 1 PACKAGE (0270-0149-57) > 300 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength66%;10%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength52%;8%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 012

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength30%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
Chubb
UBS
Cerilliant
Argus Health
Colorcon
Citi
Teva
Medtronic

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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