Details for New Drug Application (NDA): 207751
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The generic ingredient in ZOLEDRONIC ACID is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 207751
Tradename: | ZOLEDRONIC ACID |
Applicant: | Eugia Pharma |
Ingredient: | zoledronic acid |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207751
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 207751 | ANDA | AuroMedics Pharma LLC | 55150-266 | 55150-266-05 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-266-05) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 4MG BASE/5ML | ||||
Approval Date: | Sep 26, 2016 | TE: | RLD: | No |
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