Application 202653
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GATIFLOXACIN | GATIFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.5% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57297-435 | Gatifloxacin | Gatifloxacin | LUPIN LIMITED | ANDA | Current |
| 68180-435 | Gatifloxacin | Gatifloxacin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-435 | Gatifloxacin | Gatifloxacin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-435 | Gatifloxacin | Gatifloxacin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10090 | ORIG | 2013-08-29 |