Application 022221
- Type
- NDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AKTEN | LIDOCAINE HYDROCHLORIDE | GEL;OPHTHALMIC | 3.5% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17478-792 | Akten | Lidocaine Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-792 | Akten | Lidocaine Hydrochloride | Akorn | NDA | Current |
| 17478-792 | Akten | Lidocaine Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-792 | Akten | Lidocaine Hydrochloride | Akorn | NDA | Current |
| 82584-792 | AKTEN | LIDOCAINE HYDROCHLORIDE ANHYDROUS | Thea Pharma Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84293 | SUPPL | 2025-11-25 |
| 84271 | SUPPL | 2025-11-24 |
| 70365 | SUPPL | 2022-03-02 |
| 70305 | SUPPL | 2022-03-01 |
| 17102 | SUPPL | 2014-03-13 |
| 7068 | SUPPL | 2014-03-13 |
| 17101 | SUPPL | 2012-12-10 |
| 44707 | ORIG | 2009-09-01 |
| 42455 | ORIG | 2009-09-01 |
| 29422 | ORIG | 2008-10-09 |
| 17100 | ORIG | 2008-10-09 |
| 53324 | ORIG | 1900-01-01 |
| 53323 | ORIG | 1900-01-01 |
| 53322 | ORIG | 1900-01-01 |