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Serving leading biopharmaceutical companies globally:

Argus Health
Baxter
McKesson
Dow
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Deloitte
Colorcon
Merck
Cipla
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Generated: October 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203987

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NDA 203987 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 NDA: 203987

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

Pharmacology for NDA: 203987

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 203987

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBANDRONATE SODIUM
ibandronate sodium
INJECTABLE;INTRAVENOUS 203987 ANDA Heritage Pharmaceuticals Inc. 23155-162 23155-162-31 3 mL in 1 VIAL, GLASS (23155-162-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 3MG BASE/3ML
Approval Date:Sep 2, 2014TE:APRLD:No


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US Department of Justice
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US Army

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