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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 215417


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NDA 215417 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, Mankind Pharma, 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 thirty NDAs. It is available from twenty-two 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 215417
Tradename:CYANOCOBALAMIN
Applicant:Sola Pharms
Ingredient:cyanocobalamin
Patents:0
Pharmacology for NDA: 215417
Suppliers and Packaging for NDA: 215417
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 215417 ANDA SOLA Pharmaceuticals 70512-840 70512-840-25 25 VIAL, MULTI-DOSE in 1 CARTON (70512-840-25) / 1 mL in 1 VIAL, MULTI-DOSE (70512-840-01)
CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 215417 ANDA Asclemed USA, Inc. 76420-618 76420-618-25 25 VIAL, MULTI-DOSE in 1 CARTON (76420-618-25) / 1 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

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

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