Details for New Drug Application (NDA): 210795
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NDA 210795 describes KRINTAFEL, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. Additional details are available on the KRINTAFEL profile page.
The generic ingredient in KRINTAFEL is tafenoquine succinate. Two suppliers are listed for this compound. Additional details are available on the tafenoquine succinate profile page.
The generic ingredient in KRINTAFEL is tafenoquine succinate. Two suppliers are listed for this compound. Additional details are available on the tafenoquine succinate profile page.
Summary for 210795
| Tradename: | KRINTAFEL |
| Applicant: | Glaxosmithkline |
| Ingredient: | tafenoquine succinate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210795
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KRINTAFEL | tafenoquine succinate | TABLET;ORAL | 210795 | NDA | GlaxoSmithKline LLC | 0173-0889 | 0173-0889-39 | 2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jul 20, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 20, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE RADICAL CURE (PREVENTION OF RELAPSE) OF PLASMODIUM VIVAX MALARIA IN PATIENTS AGED 16 YEARS AND OLDER WHO ARE RECEIVING APPROPRIATE ANTIMALARIAL THERAPY FOR ACUTE P. VIVAX INFECTION | ||||||||
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