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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202548

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NDA 202548 describes ZOLEDRONIC ACID, which is a drug marketed by Accord Hlthcare, Acs Dobfar Info Sa, Actavis Inc, Akorn, Akorn Inc, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in thirty NDAs. It is available from twenty-two suppliers. Additional details are available on the ZOLEDRONIC ACID profile page.

The generic ingredient in ZOLEDRONIC ACID is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Summary for 202548

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202548

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 202548

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202548 ANDA Akorn 17478-327 17478-327-45 4 VIAL, SINGLE-USE in 1 CARTON (17478-327-45) > 5 mL in 1 VIAL, SINGLE-USE
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202548 ANDA Akorn 17478-327 17478-327-05 1 VIAL, SINGLE-USE in 1 CARTON (17478-327-05) > 5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/5ML
Approval Date:May 22, 2014TE:APRLD:No


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