Details for New Drug Application (NDA): 078997
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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 078997
Tradename: | IBANDRONATE SODIUM |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | ibandronate sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078997
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078997 | ANDA | Dr. Reddy's Laboratories Limited | 55111-575 | 55111-575-03 | 3 BLISTER PACK in 1 CARTON (55111-575-03) / 1 TABLET in 1 BLISTER PACK (55111-575-11) |
IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078997 | ANDA | Dr. Reddy's Laboratories Limited | 55111-575 | 55111-575-43 | 1 BLISTER PACK in 1 CARTON (55111-575-43) / 3 TABLET in 1 BLISTER PACK (55111-575-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Apr 30, 2012 | TE: | AB | RLD: | No |
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