Details for New Drug Application (NDA): 207341
✉ Email this page to a colleague
The generic ingredient in ZOLEDRONIC ACID is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 207341
Tradename: | ZOLEDRONIC ACID |
Applicant: | Bpi Labs |
Ingredient: | zoledronic acid |
Patents: | 0 |
Suppliers and Packaging for NDA: 207341
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 207341 | ANDA | BPI Labs, LLC | 54288-100 | 54288-100-01 | 1 VIAL in 1 CARTON (54288-100-01) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 4MG BASE/5ML | ||||
Approval Date: | Dec 29, 2017 | TE: | AP | RLD: | No |
Complete Access Available with Subscription