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Generated: March 22, 2019

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Details for New Drug Application (NDA): 205332

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NDA 205332 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 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. Thirteen suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
Summary for 205332
Applicant:Aurobindo Pharma Ltd
Ingredient:ibandronate sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 205332
Suppliers and Packaging for NDA: 205332
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 205332 ANDA AuroMedics Pharma LLC 55150-191 55150-191-83 1 SYRINGE, GLASS in 1 CARTON (55150-191-83) > 3 mL in 1 SYRINGE, GLASS

Profile for product number 001

Approval Date:Aug 19, 2015TE:APRLD:No

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