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Last Updated: July 18, 2024

Details for New Drug Application (NDA): 215107

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NDA 215107 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 215107
Applicant:Sagent Pharms Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 215107
Suppliers and Packaging for NDA: 215107
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 215107 ANDA Sagent Pharmaceuticals 25021-502 25021-502-01 25 VIAL in 1 CARTON (25021-502-01) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Nov 15, 2022TE:APRLD:No

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