Application 021902
- Type
- NDA
- Sponsor
- FOUGERA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VEREGEN | SINECATECHINS | OINTMENT;TOPICAL | 15% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10337-450 | Veregen | sinecatechins | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-450 | Veregen | sinecatechins | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-450 | Veregen | sinecatechins | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-450 | Veregen | sinecatechins | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 62559-385 | Veregen | sinecatechins | ANI Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56947 | SUPPL | 2018-12-21 |
| 56898 | SUPPL | 2018-12-20 |
| 6416 | SUPPL | 2013-03-04 |
| 37845 | SUPPL | 2012-11-26 |
| 6415 | SUPPL | 2012-11-21 |
| 6414 | SUPPL | 2008-09-23 |
| 16542 | SUPPL | 2008-09-19 |
| 6413 | SUPPL | 2008-01-09 |
| 16541 | SUPPL | 2007-12-27 |
| 28808 | SUPPL | 2007-06-07 |
| 16540 | SUPPL | 2007-06-04 |
| 42342 | ORIG | 2007-01-08 |
| 28807 | ORIG | 2006-11-06 |
| 16539 | ORIG | 2006-11-06 |