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Merck
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Chinese Patent Office

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090853

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NDA 090853 describes IBANDRONATE SODIUM, which is a drug marketed by Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Mylan Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Sun Pharm Industries, and Watson Labs Teva, and is included in fifteen NDAs. It is available from thirteen suppliers. Additional details are available on the IBANDRONATE SODIUM profile page.

The generic ingredient in IBANDRONATE SODIUM is ibandronate sodium. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
Summary for 090853
Tradename:IBANDRONATE SODIUM
Applicant:Sun Pharm Inds Ltd
Ingredient:ibandronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090853
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 090853
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 090853 ANDA Sun Pharmaceutical Industries Limited 62756-218 N 62756-218-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 3MG BASE/3ML
Approval Date:Feb 14, 2014TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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Federal Trade Commission
Medtronic
Queensland Health
Cerilliant
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