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Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080737

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NDA 080737 describes CYANOCOBALAMIN, which is a drug marketed by Somerset Theraps Llc, Abraxis Pharm, West-ward Pharms Int, Watson Labs, Mylan Labs Ltd, Luitpold, Mylan Institutional, Solopak, Wyeth Ayerst, Fresenius Kabi Usa, Sanofi Aventis Us, West Ward, Akorn, Lyphomed, Warner Chilcott, Dell Labs, and Mallinckrodt, and is included in nineteen NDAs. It is available from eleven suppliers. Additional details are available on the CYANOCOBALAMIN profile page.

The generic ingredient in CYANOCOBALAMIN is cyanocobalamin; cyanocobalamin co-57; intrinsic factor. There are nine drug master file entries for this compound. Additional details are available on the cyanocobalamin; cyanocobalamin co-57; intrinsic factor profile page.

Summary for NDA: 080737

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

Pharmacology for NDA: 080737

Ingredient-typeVitamin B 12

Suppliers and Packaging for NDA: 080737

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYANOCOBALAMIN
cyanocobalamin
INJECTABLE;INJECTION 080737 ANDA American Regent, Inc. 0517-0031 0517-0031-25 25 VIAL, SINGLE-USE in 1 TRAY (0517-0031-25) > 1 mL in 1 VIAL, SINGLE-USE
CYANOCOBALAMIN
cyanocobalamin
INJECTABLE;INJECTION 080737 ANDA American Regent, Inc. 0517-0032 0517-0032-25 25 VIAL, MULTI-DOSE in 1 TRAY (0517-0032-25) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

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:

Accenture
Daiichi Sankyo
McKinsey
Citi
Covington
Cantor Fitzgerald
Dow
Johnson and Johnson
Julphar
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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