Application 074805
- Type
- ANDA
- Sponsor
- BAUSCH AND LOMB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUNISOLIDE | FLUNISOLIDE | SPRAY, METERED;NASAL | 0.025MG/SPRAY | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24208-344 | Flunisolide | Flunisolide | Bausch & Lomb Incorporated | ANDA | Current |
| 24208-344 | Flunisolide | Flunisolide | Bausch & Lomb Incorporated | ANDA | Current |
| 70518-0671 | Flunisolide | Flunisolide | REMEDYREPACK INC. | ANDA | Current |
| 70518-0671 | Flunisolide | Flunisolide | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8450 | ORIG | 2003-04-09 |