Application 216212
- Type
- ANDA
- Sponsor
- CADILA PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | GRANULE;ORAL | EQ 200MG BASE/5ML | No | No |
| 002 | ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | GRANULE;ORAL | EQ 400MG BASE/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71209-102 | Erythromycin ethylsuccinate | Erythromycin ethylsuccinate | Cadila Pharmaceuticals Limited | ANDA | Current |
| 71209-103 | Erythromycin ethylsuccinate | Erythromycin ethylsuccinate | Cadila Pharmaceuticals Limited | ANDA | Current |