Details for New Drug Application (NDA): 204684
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The generic ingredient in IMPAVIDO is miltefosine. One supplier is listed for this compound. Additional details are available on the miltefosine profile page.
Summary for 204684
Tradename: | IMPAVIDO |
Applicant: | Knight Theraps |
Ingredient: | miltefosine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204684
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IMPAVIDO | miltefosine | CAPSULE;ORAL | 204684 | NDA | Profounda, Inc. | 69051-300 | 69051-300-01 | 2 BLISTER PACK in 1 CARTON (69051-300-01) / 14 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 19, 2014 | TE: | RLD: | Yes |
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