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Details for New Drug Application (NDA): 079003

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NDA 079003 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 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. There are two tentative approvals for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for NDA: 079003

Watson Labs Inc
ibandronate sodium
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for NDA: 079003


Suppliers and Packaging for NDA: 079003

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ibandronate sodium
TABLET;ORAL 079003 ANDA Watson Laboratories, Inc. 0591-3770 0591-3770-11 1 TABLET in 1 BLISTER PACK (0591-3770-11)
ibandronate sodium
TABLET;ORAL 079003 ANDA Watson Laboratories, Inc. 0591-3770 0591-3770-31 3 BLISTER PACK in 1 BOX (0591-3770-31) > 1 TABLET in 1 BLISTER PACK (0591-3770-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 20, 2012TE:ABRLD:No

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