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, Avet Lifesciences, Chemi Spa, Eugia Pharma, Nang Kuang Pharm Co, Pharmobedient, Sun Pharm, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Ltd, Macleods Pharms, Orbion Pharms, Sun Pharm Industries, and Watson Labs Teva, and is included in sixteen NDAs. It is available from nine suppliers. Additional details are available on the IBANDRONATE SODIUM profile page.
The generic ingredient in IBANDRONATE SODIUM is ibandronate sodium. There is one drug master file entry for this compound. Nine 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
Summary for 205332
| Tradename: | IBANDRONATE SODIUM |
| Applicant: | Eugia Pharma |
| Ingredient: | ibandronate sodium |
| Patents: | 0 |
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 | Eugia US 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
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 3MG BASE/3ML | ||||
| Approval Date: | Aug 19, 2015 | TE: | AP | RLD: | No | ||||
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