Application 050536
- Type
- NDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERYC | ERYTHROMYCIN | CAPSULE, DELAYED REL PELLETS;ORAL | 250MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68308-250 | erythromycin | erythromycin | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-250 | erythromycin | erythromycin | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-250 | erythromycin | erythromycin | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53811 | SUPPL | 2018-04-24 |
| 53799 | SUPPL | 2018-04-24 |
| 38967 | SUPPL | 2013-03-26 |
| 7794 | SUPPL | 2013-03-22 |
| 30059 | SUPPL | 2012-02-21 |
| 38968 | SUPPL | 2012-02-17 |
| 17856 | SUPPL | 2008-02-25 |
| 7793 | SUPPL | 2008-02-25 |
| 30058 | SUPPL | 2006-01-20 |
| 38966 | SUPPL | 2006-01-13 |
| 30056 | SUPPL | 2004-02-27 |
| 30057 | SUPPL | 2003-12-22 |