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Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204502

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NDA 204502 describes IBANDRONATE SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Watson Labs Teva, Apotex Inc, Sagent Pharms, Sun Pharm Inds Ltd, Accord Hlthcare, Mylan Labs Ltd, Emcure Pharms Ltd, Mylan Pharms Inc, Sun Pharm Inds, Dr Reddys Labs Ltd, and Orchid Hlthcare, and is included in fourteen NDAs. It is available from twelve 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 204502

Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204502


Suppliers and Packaging for NDA: 204502

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ibandronate sodium
TABLET;ORAL 204502 ANDA Aurobindo Pharma Limited 65862-237 65862-237-03 1 BLISTER PACK in 1 CARTON (65862-237-03) > 3 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 11, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
Farmers Insurance
Johnson and Johnson

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