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Application 210795
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KRINTAFEL | TAFENOQUINE SUCCINATE | TABLET;ORAL | EQ 150MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0173-0889 | Krintafel | tafenoquine succinate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0889 | Krintafel | tafenoquine succinate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0889 | Krintafel | tafenoquine succinate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0889 | Krintafel | tafenoquine succinate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0889 | Krintafel | tafenoquine succinate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0889 | Krintafel | tafenoquine succinate | GlaxoSmithKline LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65250 | SUPPL | 2020-11-17 |
| 65232 | SUPPL | 2020-11-16 |
| 55295 | ORIG | 2018-08-24 |
| 54940 | ORIG | 2018-07-23 |
| 54939 | ORIG | 2018-07-20 |