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Details for New Drug Application (NDA): 202571

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NDA 202571 describes ZOLEDRONIC ACID, which is a drug marketed by Emcure Pharms Ltd, Fresenius Kabi Usa, Hospira Inc, Gland Pharma Ltd, Akorn, Sun Pharma Global, Usv North America, Acs Dobfar Info Sa, Akorn Inc, Mylan Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Pharmaceutics, Apotex Inc, Pharms, Actavis Inc, Hikma Farmaceutica, and Sagent Pharms, and is included in twenty-six NDAs. It is available from nineteen 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 suppliers are listed for this compound. There are twelve tentative approvals for this compound. Additional details are available on the zoledronic acid profile page.

Summary for NDA: 202571

Tradename:
ZOLEDRONIC ACID
Applicant:
Pharms
Ingredient:
zoledronic acid
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202571

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 202571

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION) 202571 ANDA JHP Pharmaceuticals, LLC. 42023-167 42023-167-01 1 VIAL, GLASS in 1 CARTON (42023-167-01) > 5 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/5ML
Approval Date:May 7, 2013TE:APRLD:No


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