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, Avet Lifesciences, Eugia Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sun Pharm, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Norvium Bioscience, Orbion Pharms, Sun Pharm Industries, and Watson Labs Teva, and is included in sixteen NDAs. It is available from ten 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. Ten suppliers are listed for this compound. 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. Ten suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
Summary for 078948
| Tradename: | IBANDRONATE SODIUM |
| Applicant: | Apotex Inc |
| Ingredient: | ibandronate sodium |
| Patents: | 0 |
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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Mar 19, 2012 | TE: | AB | RLD: | No | ||||
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