Application 076615
- Type
- ANDA
- Sponsor
- HI TECH PHARMA
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 |
|---|---|---|---|---|---|
| 50383-024 | Ofloxacin | Ofloxacin | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-024 | Ofloxacin | Ofloxacin | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-024 | Ofloxacin | Ofloxacin | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-024 | Ofloxacin | Ofloxacin | Akorn | ANDA | Current |
| 68387-106 | Ofloxacin | Ofloxacin | Keltman Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8933 | ORIG | 2004-05-26 |