Application 211975
- Type
- ANDA
- Sponsor
- TORRENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERYTHROMYCIN | ERYTHROMYCIN | TABLET, DELAYED RELEASE;ORAL | 250MG | No | No |
| 002 | ERYTHROMYCIN | ERYTHROMYCIN | TABLET, DELAYED RELEASE;ORAL | 500MG | No | No |
| 003 | ERYTHROMYCIN | ERYTHROMYCIN | TABLET, DELAYED RELEASE;ORAL | 333MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13668-586 | ERYTHROMYCIN | ERYTHROMYCIN | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-586 | ERYTHROMYCIN | ERYTHROMYCIN | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-588 | ERYTHROMYCIN | ERYTHROMYCIN | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-588 | ERYTHROMYCIN | ERYTHROMYCIN | Torrent Pharmaceuticals Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79391 | SUPPL | 2024-08-14 |