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Serving 500+ biopharmaceutical companies globally:

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Generated: July 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080557

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NDA 080557 describes VIBISONE, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from three suppliers. Additional details are available on the VIBISONE profile page.

The generic ingredient in VIBISONE is cyanocobalamin. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.

Summary for NDA: 080557

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

Pharmacology for NDA: 080557

Ingredient-typeVitamin B 12

Suppliers and Packaging for NDA: 080557

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYANOCOBALAMIN
cyanocobalamin
INJECTABLE;INJECTION 080557 ANDA RX PHARMA-PACK, INC. 49836-527 49836-527-01 1 KIT in 1 CARTON (49836-527-01) * 1 mL in 1 VIAL, MULTI-DOSE * .55 mL in 1 POUCH
CYANOCOBALAMIN
cyanocobalamin
INJECTABLE;INJECTION 080557 ANDA APP Pharmaceuticals, LLC 63323-044 63323-044-01 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) > 1 mL in 1 VIAL, MULTI-DOSE

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Julphar
UBS
Deloitte
Moodys
US Department of Justice
McKinsey
Federal Trade Commission
Boehringer Ingelheim
Fish and Richardson
Harvard Business School

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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