Application 020258
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IOPIDINE | APRACLONIDINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0065-0665 | Iopidine | apraclonidine | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0665 | Iopidine | apraclonidine | Alcon Laboratories, Inc. | NDA | Current |
| 61314-665 | Apraclonidine | Apraclonidine | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 61314-665 | Apraclonidine | Apraclonidine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |