Application 211991
- Type
- ANDA
- Sponsor
- PAR PHARM INC
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 |
|---|---|---|---|---|---|
| 0254-1020 | Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | Par Pharmaceutical, Inc. | ANDA | Current |
| 0254-1020 | Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | Par Pharmaceutical, Inc. | ANDA | Current |
| 0254-1020 | Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | Par Pharmaceutical, Inc. | ANDA | Current |
| 0254-1021 | Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | Par Pharmaceutical, Inc. | ANDA | Current |
| 0254-1021 | Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61131 | ORIG | 2019-12-03 |