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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 091363


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NDA 091363 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 091363
Tradename:ZOLEDRONIC ACID
Applicant:Dr Reddys Labs Ltd
Ingredient:zoledronic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091363
Suppliers and Packaging for NDA: 091363
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 091363 ANDA Dr.Reddy's Laboratories Inc 43598-331 43598-331-11 100 mL in 1 BOTTLE, GLASS (43598-331-11)
ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 091363 ANDA Dr.Reddy's Laboratories Ltd 55111-688 55111-688-52 100 mL in 1 BOTTLE, GLASS (55111-688-52)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 5MG BASE/100ML
Approval Date:Mar 29, 2013TE:APRLD:No

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