Application 065146
- Type
- ANDA
- Sponsor
- YUNG SHIN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFACLOR | CEFACLOR | CAPSULE;ORAL | EQ 250MG BASE | No | No |
| 002 | CEFACLOR | CEFACLOR | CAPSULE;ORAL | EQ 500MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-1602 | Cefaclor | Cefaclor | A-S Medication Solutions | ANDA | Current |
| 61442-171 | Cefaclor | Cefaclor | Carlsbad Technology, Inc. | ANDA | Current |
| 61442-172 | Cefaclor | Cefaclor | Carlsbad Technology, Inc. | ANDA | Current |
| 63629-1007 | Cefaclor | Cefaclor | Bryant Ranch Prepack | ANDA | Current |
| 63629-1007 | Cefaclor | Cefaclor | Bryant Ranch Prepack | ANDA | Current |