Application 022268
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COARTEM | ARTEMETHER; LUMEFANTRINE | TABLET;ORAL | 20MG;120MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0568 | COARTEM | artemether and lumefantrine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0568 | COARTEM | artemether and lumefantrine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0568 | COARTEM | artemether and lumefantrine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0568 | COARTEM | artemether and lumefantrine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0568 | COARTEM | artemether and lumefantrine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 76413-154 | COARTEM | artemether and lumefantrine | Central Texas Community Health Centers | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59589 | SUPPL | 2019-08-06 |
| 59582 | SUPPL | 2019-08-06 |
| 51013 | SUPPL | 2018-01-10 |
| 51001 | SUPPL | 2018-01-09 |
| 38473 | SUPPL | 2015-03-20 |
| 29499 | SUPPL | 2015-03-20 |
| 38472 | SUPPL | 2013-05-01 |
| 7140 | SUPPL | 2013-05-01 |
| 17174 | SUPPL | 2012-08-07 |
| 7139 | SUPPL | 2012-08-07 |
| 17173 | SUPPL | 2010-02-23 |
| 7138 | SUPPL | 2010-02-23 |
| 24270 | ORIG | 2009-07-08 |
| 21973 | ORIG | 2009-07-08 |
| 38471 | ORIG | 2009-04-16 |
| 7137 | ORIG | 2009-04-14 |