Details for New Drug Application (NDA): 202923
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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-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 202923
Tradename: | ZOLEDRONIC ACID |
Applicant: | Usv |
Ingredient: | zoledronic acid |
Patents: | 0 |
Suppliers and Packaging for NDA: 202923
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 202923 | ANDA | Fresenius Kabi USA, LLC | 63323-961 | 63323-961-98 | 1 VIAL in 1 CARTON (63323-961-98) / 5 mL in 1 VIAL |
ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 202923 | ANDA | Westminster Pharmaceuticals, LLC | 69367-190 | 69367-190-50 | 1 VIAL in 1 CARTON (69367-190-50) / 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: | Sep 4, 2014 | TE: | AP | RLD: | No |
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