Details for New Drug Application (NDA): 205254
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NDA 205254 describes ZOLEDRONIC ACID, which is a drug marketed by Accord Hlthcare, Actavis Inc, Amneal, Apotex, Avet Lifesciences, Bpi Labs, Breckenridge, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Inforlife, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms Inc, Shilpa, Sun Pharma Global, and USV, and is included in thirty-seven NDAs. It is available from twenty-one suppliers. Additional details are available on the ZOLEDRONIC ACID profile page.
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.
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 205254
| Tradename: | ZOLEDRONIC ACID |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | zoledronic acid |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205254
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 205254 | ANDA | Mylan Institutional LLC | 67457-794 | 67457-794-10 | 1 BAG in 1 POUCH (67457-794-10) / 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: | Oct 27, 2017 | TE: | AP | RLD: | No | ||||
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