Details for New Drug Application (NDA): 205749
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NDA 205749 describes ZOLEDRONIC, which is a drug marketed by Gland Pharma Ltd, 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, 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-eight NDAs. It is available from two suppliers. Additional details are available on the ZOLEDRONIC profile page.
The generic ingredient in ZOLEDRONIC 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.
The generic ingredient in ZOLEDRONIC 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 205749
| Tradename: | ZOLEDRONIC |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | zoledronic acid |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205749
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZOLEDRONIC | zoledronic acid | INJECTABLE;INTRAVENOUS | 205749 | ANDA | Gland Pharma Limited | 68083-142 | 68083-142-01 | 1 VIAL in 1 CARTON (68083-142-01) / 100 mL in 1 VIAL |
| ZOLEDRONIC | zoledronic acid | INJECTABLE;INTRAVENOUS | 205749 | ANDA | Athenex Pharmaceutical Division, LLC. | 70860-210 | 70860-210-51 | 1 VIAL, SINGLE-USE in 1 CARTON (70860-210-51) / 100 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 4MG BASE/100ML | ||||
| Approval Date: | Jun 29, 2018 | TE: | AP | RLD: | No | ||||
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