Details for New Drug Application (NDA): 209315
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NDA 209315 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 sixteen 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.
Summary for 209315
| Tradename: | ARSENIC TRIOXIDE |
| Applicant: | Ingenus Pharms Llc |
| Ingredient: | arsenic trioxide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209315
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 209315 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-438 | 50742-438-10 | 1 VIAL, GLASS in 1 CARTON (50742-438-10) / 10 mL in 1 VIAL, GLASS |
| ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 209315 | ANDA | Athenex Pharmaceutical Division, LLC | 70860-217 | 70860-217-10 | 1 VIAL in 1 CARTON (70860-217-10) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Nov 15, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | Jan 14, 2021 | TE: | RLD: | No | |||||
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