Application 065380
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUPRAX | CEFIXIME | TABLET, CHEWABLE;ORAL | 100MG | No | No |
| 002 | SUPRAX | CEFIXIME | TABLET, CHEWABLE;ORAL | 150MG | No | No |
| 003 | SUPRAX | CEFIXIME | TABLET, CHEWABLE;ORAL | 200MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27437-203 | SUPRAX | cefixime | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 27437-203 | SUPRAX | cefixime | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 27437-205 | SUPRAX | cefixime | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 27437-205 | SUPRAX | cefixime | Lupin Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8395 | ORIG | 2010-10-29 |