Details for New Drug Application (NDA): 210739
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NDA 210739 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 210739
| Tradename: | ARSENIC TRIOXIDE |
| Applicant: | Amneal |
| Ingredient: | arsenic trioxide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210739
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 210739 | ANDA | Amneal Pharmaceuticals LLC | 70121-1483 | 70121-1483-7 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1483-7) / 10 mL in 1 VIAL, SINGLE-DOSE (70121-1483-1) |
| ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 210739 | ANDA | Amneal Pharmaceuticals LLC | 70121-1658 | 70121-1658-1 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1658-1) / 6 mL in 1 VIAL, SINGLE-DOSE (70121-1658-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Jan 25, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | Aug 19, 2021 | TE: | AP | RLD: | No | ||||
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