Application 061905
- Type
- ANDA
- Sponsor
- ARBOR PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | E.E.S. 400 | ERYTHROMYCIN ETHYLSUCCINATE | TABLET;ORAL | EQ 400MG BASE | No | No |
| 002 | E.E.S. 400 | ERYTHROMYCIN ETHYLSUCCINATE | TABLET;ORAL | EQ 400MG BASE | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24338-100 | E.E.S | Erythromycin Ethylsuccinate | Arbor Pharmaceuticals, Inc. | ANDA | Current |
| 24338-100 | E.E.S | Erythromycin Ethylsuccinate | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | ANDA | Current |
| 24338-100 | E.E.S | Erythromycin Ethylsuccinate | Arbor Pharmaceuticals, Inc. | ANDA | Current |
| 24338-100 | E.E.S | Erythromycin Ethylsuccinate | Arbor Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 39396 | SUPPL | 2014-01-31 |