Application 019779
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IOPIDINE | APRACLONIDINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 1% BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0065-0660 | IOPIDINE | apraclonidine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0660 | IOPIDINE | apraclonidine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0660 | IOPIDINE | apraclonidine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0660 | IOPIDINE | apraclonidine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85531 | SUPPL | 2026-03-26 |
| 85419 | SUPPL | 2026-03-20 |
| 52811 | SUPPL | 2018-03-05 |
| 52792 | SUPPL | 2018-03-02 |
| 47974 | SUPPL | 2017-04-12 |
| 47891 | SUPPL | 2017-04-07 |
| 33949 | SUPPL | 2004-12-30 |
| 19213 | SUPPL | 2004-12-30 |
| 11713 | SUPPL | 2004-12-30 |
| 1613 | SUPPL | 2004-12-30 |
| 1612 | SUPPL | 2003-06-08 |
| 19212 | SUPPL | 2002-03-22 |
| 11712 | SUPPL | 2002-03-22 |