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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 209578


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NDA 209578 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-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 209578
Tradename:ZOLEDRONIC ACID
Applicant:Gland Pharma Ltd
Ingredient:zoledronic acid
Patents:0
Pharmacology for NDA: 209578
Suppliers and Packaging for NDA: 209578
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 209578 ANDA BluePoint Laboratories 68001-611 68001-611-33 1 BAG in 1 CARTON (68001-611-33) / 100 mL in 1 BAG
ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 209578 ANDA Gland Pharma Limited 68083-256 68083-256-01 1 BAG in 1 CARTON (68083-256-01) / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 5MG BASE/100ML
Approval Date:Aug 8, 2019TE:APRLD:No

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