Application 065115
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | No | No |
| 002 | CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | No | No |
| 003 | CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | FOR SUSPENSION;ORAL | EQ 500MG BASE/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63304-973 | CEFADROXIL | cefadroxil monohydrate | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-974 | CEFADROXIL | cefadroxil monohydrate | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39416 | ORIG | 2003-12-23 |
| 22313 | ORIG | 2003-12-23 |
| 8387 | ORIG | 2003-12-23 |