Details for New Drug Application (NDA): 215359
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NDA 215359 describes ARSENIC TRIOXIDE, which is a drug marketed by Amneal, Amring Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Ingenus Pharms Llc, Nexus, Orbicular, Penn Life, Sandoz, and Zydus Pharms, and is included in eleven NDAs. It is available from fifteen suppliers. Additional details are available on the ARSENIC TRIOXIDE profile page.
The generic ingredient in ARSENIC TRIOXIDE is arsenic trioxide. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.
The generic ingredient in ARSENIC TRIOXIDE is arsenic trioxide. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.
Summary for 215359
| Tradename: | ARSENIC TRIOXIDE |
| Applicant: | Sandoz |
| Ingredient: | arsenic trioxide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215359
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 215359 | ANDA | Sandoz Inc | 0781-3498 | 0781-3498-94 | 1 VIAL in 1 CARTON (0781-3498-94) / 6 mL in 1 VIAL |
| ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 215359 | ANDA | Sandoz Inc | 0781-3498 | 0781-3498-95 | 10 VIAL in 1 CARTON (0781-3498-95) / 6 mL in 1 VIAL (0781-3498-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | Dec 2, 2021 | TE: | AP | RLD: | No | ||||
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