You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 21, 2024

Details for New Drug Application (NDA): 080737


✉ Email this page to a colleague

« Back to Dashboard


NDA 080737 describes CYANOCOBALAMIN, which is a drug marketed by Abraxis Pharm, Am Regent, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Luitpold, Lyphomed, Mylan Institutional, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, Sanofi Aventis Us, Sola Pharms, Solopak, Somerset Theraps Llc, Vitruvias Therap, Warner Chilcott, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Xiromed, Zydus Pharms, Lupin, Padagis Israel, and West Ward, and is included in twenty-nine NDAs. It is available from twenty-one suppliers. Additional details are available on the CYANOCOBALAMIN profile page.

The generic ingredient in CYANOCOBALAMIN is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.
Summary for 080737
Tradename:CYANOCOBALAMIN
Applicant:Am Regent
Ingredient:cyanocobalamin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 080737
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, MULTI-DOSE in 1 TRAY (0517-0031-25) / 1 mL in 1 VIAL, MULTI-DOSE (0517-0031-01)
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 (0517-0032-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.