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Colorcon
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Chinese Patent Office
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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078948

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NDA 078948 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. Fifteen suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for 078948

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

Pharmacology for NDA: 078948

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 078948

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 078948 ANDA Golden State Medical Supply, Inc. 60429-643 60429-643-73 3 BLISTER PACK in 1 PACKAGE (60429-643-73) > 1 TABLET, FILM COATED in 1 BLISTER PACK
IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 078948 ANDA Apotex Corp 60505-2795 60505-2795-0 3 BLISTER PACK in 1 PACKAGE (60505-2795-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 19, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Express Scripts
Novartis
Argus Health
Cerilliant
US Army
Covington
Medtronic
Julphar
Fuji
Baxter

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