Details for New Drug Application (NDA): 204368
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NDA 204368 describes OXALIPLATIN, which is a drug marketed by Accord Hlthcare, Actavis, Actavis Totowa, Am Regent, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hospira Inc, Hospira Worldwide, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Qilu Pharm Hainan, Sandoz, Sun Pharm, and Teva Pharms, and is included in twenty-seven NDAs. It is available from eighteen suppliers. Additional details are available on the OXALIPLATIN profile page.
The generic ingredient in OXALIPLATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
The generic ingredient in OXALIPLATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
Summary for 204368
| Tradename: | OXALIPLATIN |
| Applicant: | Qilu Pharm Hainan |
| Ingredient: | oxaliplatin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204368
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXALIPLATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 204368 | ANDA | Apotex Corp. | 60505-6132 | 60505-6132-6 | 1 VIAL in 1 CARTON (60505-6132-6) / 10 mL in 1 VIAL |
| OXALIPLATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 204368 | ANDA | Apotex Corp. | 60505-6132 | 60505-6132-7 | 1 VIAL in 1 CARTON (60505-6132-7) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/10ML (5MG/ML) | ||||
| Approval Date: | Jun 7, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 100MG/20ML (5MG/ML) | ||||
| Approval Date: | Jun 7, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 200MG/40ML (5MG/ML) | ||||
| Approval Date: | Jun 7, 2016 | TE: | RLD: | No | |||||
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