Application 050297
- Type
- NDA
- Sponsor
- ARBOR PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | E.E.S. | ERYTHROMYCIN ETHYLSUCCINATE | TABLET, CHEWABLE;ORAL | EQ 200MG BASE | No | No |
| 003 | ERYPED | ERYTHROMYCIN ETHYLSUCCINATE | TABLET, CHEWABLE;ORAL | EQ 200MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30003 | SUPPL | 2012-08-17 |
| 38925 | SUPPL | 2012-08-16 |
| 7725 | SUPPL | 2010-11-08 |
| 17817 | SUPPL | 2009-01-02 |
| 30002 | SUPPL | 2008-12-19 |
| 30001 | SUPPL | 2008-05-28 |
| 30000 | SUPPL | 2008-01-09 |
| 38924 | SUPPL | 2008-01-08 |
| 29999 | SUPPL | 2006-08-14 |
| 17816 | SUPPL | 2006-08-11 |
| 42640 | SUPPL | 2004-09-21 |
| 7724 | SUPPL | 2004-03-16 |
| 7723 | SUPPL | 2002-04-25 |