Application 050611
- Type
- NDA
- Sponsor
- ARBOR PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PCE | ERYTHROMYCIN | TABLET, COATED PARTICLES;ORAL | 333MG | Yes | No |
| 002 | PCE | ERYTHROMYCIN | TABLET, COATED PARTICLES;ORAL | 500MG | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53808 | SUPPL | 2018-04-24 |
| 53801 | SUPPL | 2018-04-24 |
| 30170 | SUPPL | 2012-02-06 |
| 17930 | SUPPL | 2012-02-06 |
| 30169 | SUPPL | 2011-02-07 |
| 39039 | SUPPL | 2011-01-31 |
| 7886 | SUPPL | 2010-11-08 |
| 17929 | SUPPL | 2009-01-02 |
| 7887 | SUPPL | 2008-12-19 |
| 7885 | SUPPL | 2008-05-28 |
| 7884 | SUPPL | 2008-01-09 |
| 39040 | SUPPL | 2008-01-08 |
| 30167 | SUPPL | 2006-08-14 |
| 39038 | SUPPL | 2006-08-11 |
| 42659 | SUPPL | 2004-09-21 |
| 30168 | SUPPL | 2004-03-16 |
| 30166 | SUPPL | 2002-04-25 |