Application 050586
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRED-G | GENTAMICIN SULFATE; PREDNISOLONE ACETATE | SUSPENSION/DROPS;OPHTHALMIC | EQ 0.3% BASE;1% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-0106 | PRED-G | gentamicin, prednisolone acetate | Allergan, Inc. | NDA | Current |
| 0023-0106 | PRED-G | gentamicin, prednisolone acetate | Allergan, Inc. | NDA | Current |
| 0023-0106 | PRED-G | gentamicin, prednisolone acetate | Allergan, Inc. | NDA | Current |