Application 022308
- Type
- NDA
- Sponsor
- BAUSCH AND LOMB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BESIVANCE | BESIFLOXACIN HYDROCHLORIDE | SUSPENSION/DROPS;OPHTHALMIC | EQ 0.6% BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24208-446 | Besivance | Besifloxacin | Bausch & Lomb Incorporated | NDA | Current |
| 24208-446 | Besivance | Besifloxacin | Bausch & Lomb Incorporated | NDA | Current |
| 24208-446 | Besivance | Besifloxacin | Bausch & Lomb Incorporated | NDA | Current |
| 24208-446 | Besivance | Besifloxacin | Bausch & Lomb Incorporated | NDA | Current |
| 50090-1241 | Besivance | Besifloxacin | A-S Medication Solutions | NDA | Current |
| 50090-1241 | Besivance | Besifloxacin | A-S Medication Solutions | NDA | Current |