Application 065336
- Type
- ANDA
- Sponsor
- YUNG SHIN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEPHALEXIN | CEPHALEXIN | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | No | No |
| 002 | CEPHALEXIN | CEPHALEXIN | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24979-154 | Cephalexin | Cephalexin | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-155 | Cephalexin | Cephalexin | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 61442-201 | Cephalexin | Cephalexin | Carlsbad Technology, Inc. | ANDA | Current |
| 61442-202 | Cephalexin | Cephalexin | Carlsbad Technology, Inc. | ANDA | Current |
| 62135-480 | Cephalexin | Cephalexin | Chartwell RX, LLC | ANDA | Current |
| 62135-481 | Cephalexin | Cephalexin | Chartwell RX, LLC | ANDA | Current |