Details for New Drug Application (NDA): 202671
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NDA 202671 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 202671
| Tradename: | IBANDRONATE SODIUM |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | ibandronate sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202671
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 202671 | ANDA | Mylan Institutional LLC | 67457-524 | 67457-524-33 | 1 SYRINGE, GLASS in 1 CARTON (67457-524-33) / 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: | Sep 2, 2014 | TE: | AP | RLD: | No | ||||
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