Application 021204
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STARLIX | NATEGLINIDE | TABLET;ORAL | 60MG | Yes | No |
| 002 | STARLIX | NATEGLINIDE | TABLET;ORAL | 120MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0351 | Starlix | nateglinide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0351 | Starlix | nateglinide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0351 | Starlix | nateglinide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0351 | Starlix | nateglinide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0352 | Starlix | nateglinide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0352 | Starlix | nateglinide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0352 | Starlix | nateglinide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0352 | Starlix | nateglinide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0352 | Starlix | nateglinide | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69166 | SUPPL | 2021-10-29 |
| 69153 | SUPPL | 2021-10-29 |
| 54246 | SUPPL | 2018-05-18 |
| 54191 | SUPPL | 2018-05-15 |
| 48133 | SUPPL | 2017-04-27 |
| 47608 | SUPPL | 2017-03-20 |
| 36342 | SUPPL | 2011-08-26 |
| 27057 | SUPPL | 2011-08-26 |
| 4631 | SUPPL | 2008-07-17 |
| 36341 | SUPPL | 2008-07-16 |
| 42020 | SUPPL | 2007-07-06 |
| 27056 | SUPPL | 2006-11-14 |
| 36340 | SUPPL | 2006-11-13 |
| 14631 | SUPPL | 2004-07-07 |
| 27055 | SUPPL | 2004-07-06 |
| 27054 | SUPPL | 2003-10-27 |
| 14630 | SUPPL | 2003-10-27 |
| 36339 | SUPPL | 2002-11-26 |
| 4630 | SUPPL | 2002-11-26 |
| 21505 | ORIG | 2002-03-18 |
| 36338 | ORIG | 2000-12-22 |
| 4629 | ORIG | 2000-12-22 |