Details for New Drug Application (NDA): 214011
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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 214011
Tradename: | ARSENIC TRIOXIDE |
Applicant: | Eugia Pharma |
Ingredient: | arsenic trioxide |
Patents: | 0 |
Suppliers and Packaging for NDA: 214011
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 214011 | ANDA | AuroMedics Pharma LLC | 55150-366 | 55150-366-10 | 10 CARTON in 1 CARTON (55150-366-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-366-01) / 6 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Oct 15, 2021 | TE: | AP | RLD: | No |
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