Application 022067
- Type
- NDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLO-PRED | PREDNISOLONE ACETATE | SUSPENSION;ORAL | EQ 5MG BASE/5ML | No | No |
| 002 | FLO-PRED | PREDNISOLONE ACETATE | SUSPENSION;ORAL | EQ 15MG BASE/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51672-1338 | Flo-Pred | Prednisolone Acetate | Taro Pharmaceuticals U.S.A., Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78720 | SUPPL | 2024-07-02 |
| 78683 | SUPPL | 2024-06-06 |
| 68137 | SUPPL | 2021-07-20 |
| 68109 | SUPPL | 2021-07-19 |
| 6813 | SUPPL | 2011-06-17 |
| 16883 | SUPPL | 2011-06-16 |
| 16882 | SUPPL | 2010-05-17 |
| 6812 | SUPPL | 2010-05-12 |
| 44673 | ORIG | 2010-02-24 |
| 42407 | ORIG | 2010-02-24 |
| 38178 | SUPPL | 2008-10-09 |
| 6811 | SUPPL | 2008-10-08 |
| 6810 | SUPPL | 2008-07-01 |
| 16881 | SUPPL | 2008-06-30 |
| 29188 | ORIG | 2008-01-23 |
| 16880 | ORIG | 2008-01-18 |