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Generated: November 22, 2017

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Details for New Drug Application (NDA): 204217

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NDA 204217 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, Mylan Labs Ltd, Akorn Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Apotex Inc, Actavis Inc, Accord Hlthcare, Hikma Farmaceutica, and Sagent Pharms, and is included in twenty-eight 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 204217

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

Pharmacology for NDA: 204217

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 204217

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION) 204217 ANDA Fresenius Kabi USA, LLC 63323-966 63323-966-00 1 VIAL, GLASS in 1 CARTON (63323-966-00) > 100 mL in 1 VIAL, GLASS
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION) 204217 ANDA Gland Pharma Limited 68083-135 68083-135-01 1 VIAL, GLASS in 1 CARTON (68083-135-01) > 100 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 5MG BASE/100ML
Approval Date:Aug 18, 2016TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

AstraZeneca
QuintilesIMS
US Army
Cerilliant
Express Scripts
Medtronic
Teva
Cantor Fitzgerald
McKesson
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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