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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202930


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NDA 202930 describes ZOLEDRONIC ACID, which is a drug marketed by Accord Hlthcare, Actavis Inc, Amneal, Apotex, Avet Lifesciences, Bpi Labs, Breckenridge, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Inforlife, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms Inc, Shilpa, Sun Pharma Global, and USV, and is included in thirty-seven NDAs. It is available from twenty-one 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 202930
Tradename:ZOLEDRONIC ACID
Applicant:Gland Pharma Ltd
Ingredient:zoledronic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202930
Suppliers and Packaging for NDA: 202930
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 202930 ANDA Gland Pharma Limited 68083-116 68083-116-01 1 VIAL in 1 CARTON (68083-116-01) / 5 mL in 1 VIAL
ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 202930 ANDA Gland Pharma Limited 68083-615 68083-615-01 1 VIAL, GLASS in 1 CARTON (68083-615-01) / 5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/5ML
Approval Date:Aug 5, 2013TE:APRLD:No

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