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Generated: April 26, 2017

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Details for New Drug Application (NDA): 078948

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NDA 078948 describes IBANDRONATE SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Watson Labs Inc, 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. There are two tentative approvals for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for NDA: 078948

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

Pharmacology for NDA: 078948


Suppliers and Packaging for NDA: 078948

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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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