Application 020741
- Type
- NDA
- Sponsor
- GEMINI LABS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRANDIN | REPAGLINIDE | TABLET;ORAL | 0.5MG | Yes | No |
| 002 | PRANDIN | REPAGLINIDE | TABLET;ORAL | 1MG | Yes | No |
| 003 | PRANDIN | REPAGLINIDE | TABLET;ORAL | 2MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0169-0081 | Prandin | repaglinide | Novo Nordisk | NDA | Current |
| 0169-0082 | Prandin | repaglinide | Novo Nordisk | NDA | Current |
| 0169-0084 | Prandin | repaglinide | Novo Nordisk | NDA | Current |
| 68151-3565 | Prandin | repaglinide | Carilion Materials Management | NDA | Current |
| 68151-3566 | Prandin | repaglinide | Carilion Materials Management | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57515 | SUPPL | 2019-02-13 |
| 57327 | SUPPL | 2019-01-23 |
| 57326 | ORIG | 2019-01-23 |
| 47153 | SUPPL | 2017-02-09 |
| 47152 | SUPPL | 2017-02-09 |
| 47145 | SUPPL | 2017-02-09 |
| 47144 | SUPPL | 2017-02-09 |
| 13325 | SUPPL | 2012-03-06 |
| 3244 | SUPPL | 2012-03-05 |
| 3243 | SUPPL | 2010-08-03 |
| 13324 | SUPPL | 2010-07-31 |
| 35253 | SUPPL | 2009-06-22 |
| 3242 | SUPPL | 2009-06-16 |
| 13323 | SUPPL | 2008-07-15 |
| 3241 | SUPPL | 2008-07-15 |
| 41637 | SUPPL | 2007-07-06 |
| 41636 | SUPPL | 2007-07-06 |
| 41635 | SUPPL | 2007-07-06 |
| 20893 | SUPPL | 2007-07-06 |
| 20892 | SUPPL | 2007-07-06 |
| 3240 | SUPPL | 2006-06-28 |
| 13322 | SUPPL | 2005-02-11 |
| 3239 | SUPPL | 2005-02-11 |
| 3238 | SUPPL | 2003-10-17 |
| 25668 | SUPPL | 2003-08-29 |
| 13321 | SUPPL | 2003-08-29 |
| 25667 | SUPPL | 2002-10-21 |
| 13320 | SUPPL | 2002-10-21 |
| 13319 | SUPPL | 2002-01-18 |
| 3237 | SUPPL | 2002-01-18 |