Details for New Drug Application (NDA): 209780
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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 209780
Tradename: | ARSENIC TRIOXIDE |
Applicant: | Nexus |
Ingredient: | arsenic trioxide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209780
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 209780 | ANDA | Nexus Pharmaceuticals Inc | 14789-600 | 14789-600-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (14789-600-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
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 |
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