Application 011961
- Type
- NDA
- Sponsor
- VALIDUS PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MARPLAN | ISOCARBOXAZID | TABLET;ORAL | 10MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 30698-032 | Marplan | isocarboxazid | Validus Pharmaceuticals L | NDA | Current |
| 30698-032 | Marplan | isocarboxazid | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-032 | Marplan | isocarboxazid | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-032 | Marplan | isocarboxazid | Validus Pharmaceuticals LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56443 | SUPPL | 2018-11-15 |
| 56407 | SUPPL | 2018-11-09 |
| 56406 | SUPPL | 2018-11-09 |
| 23093 | ORIG | 2009-11-19 |
| 33066 | SUPPL | 2007-08-14 |
| 294 | SUPPL | 2007-08-14 |
| 43999 | ORIG | 2007-05-09 |
| 33065 | SUPPL | 2005-01-13 |
| 11979 | SUPPL | 2005-01-13 |
| 20031 | SUPPL | 1998-12-14 |
| 11978 | SUPPL | 1998-08-18 |
| 10788 | SUPPL | 1998-08-18 |