Application 076513
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OFLOXACIN | OFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.3% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5186 | Ofloxacin | ofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-5186 | Ofloxacin | ofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-5186 | Ofloxacin | ofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-5209 | Ofloxacin | ofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-5209 | Ofloxacin | ofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-5209 | Ofloxacin | ofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-5210 | Ofloxacin | ofloxacin | A-S Medication Solutions | ANDA | Current |
| 60505-0560 | Ofloxacin | ofloxacin | Apotex Corp. | ANDA | Current |
| 60505-0560 | Ofloxacin | ofloxacin | Apotex Corp. | ANDA | Current |
| 60505-0560 | Ofloxacin | ofloxacin | Apotex Corp. | ANDA | Current |
| 68071-2544 | Ofloxacin | ofloxacin | NuCare Pharmaceuticaals,Inc. | ANDA | Current |
| 68788-8178 | Ofloxacin | ofloxacin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-420 | Ofloxacin | ofloxacin | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31134 | ORIG | 2004-05-26 |