Details for New Drug Application (NDA): 209578
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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 209578
Tradename: | ZOLEDRONIC ACID |
Applicant: | Gland Pharma Ltd |
Ingredient: | zoledronic acid |
Patents: | 0 |
Suppliers and Packaging for NDA: 209578
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 209578 | ANDA | BluePoint Laboratories | 68001-611 | 68001-611-33 | 1 BAG in 1 CARTON (68001-611-33) / 100 mL in 1 BAG |
ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 209578 | ANDA | Gland Pharma Limited | 68083-256 | 68083-256-01 | 1 BAG in 1 CARTON (68083-256-01) / 100 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 5MG BASE/100ML | ||||
Approval Date: | Aug 8, 2019 | TE: | AP | RLD: | No |
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