Last Updated: August 10, 2026

Details for New Drug Application (NDA): 214316


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NDA 214316 describes CYANOCOBALAMIN, which is a drug marketed by Abraxis Pharm, Am Regent, Aspiro, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Luitpold, Lyphomed, Mankind Pharma, Meitheal, Mylan Institutional, Pharmobedient, 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 thirty-two NDAs. It is available from twenty-three 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-four suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.
Summary for 214316
Tradename:CYANOCOBALAMIN
Applicant:Meitheal
Ingredient:cyanocobalamin
Patents:0
Pharmacology for NDA: 214316
Suppliers and Packaging for NDA: 214316
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 214316 ANDA Meitheal Pharmaceuticals Inc. 71288-300 71288-300-92 25 VIAL, MULTI-DOSE in 1 CARTON (71288-300-92) / 1 mL in 1 VIAL, MULTI-DOSE (71288-300-91)
CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 214316 ANDA Meitheal Pharmaceuticals Inc. 71288-300 71288-300-02 25 VIAL, MULTI-DOSE in 1 CARTON (71288-300-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-300-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Nov 15, 2024TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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