Details for New Drug Application (NDA): 206430
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The generic ingredient in VALRUBICIN is valrubicin. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the valrubicin profile page.
Summary for 206430
Tradename: | VALRUBICIN |
Applicant: | Hikma |
Ingredient: | valrubicin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206430
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALRUBICIN | valrubicin | SOLUTION;INTRAVESICAL | 206430 | ANDA | Hikma Pharmaceuticals USA Inc. | 24201-101 | 24201-101-04 | 4 VIAL in 1 CARTON (24201-101-04) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVESICAL | Strength | 40MG/ML | ||||
Approval Date: | Apr 19, 2019 | TE: | AO | RLD: | No |
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