Application 022388
- Type
- NDA
- Sponsor
- JOHNSON AND JOHNSON VISION CARE, INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ACUVUE THERAVISION WITH KETOTIFEN | ETAFILCON A LENS WITH KETOTIFEN | SOLUTION;OPTICAL | 19MCG PER LENS | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60123-019 | ACUVUE Theravision with Ketotifen | ketotifen fumarate | Johnson & Johnson Vision Care, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72102 | ORIG | 2022-09-19 |
| 70354 | ORIG | 2022-03-02 |
| 70321 | ORIG | 2022-03-01 |
| 70303 | SUPPL | 2022-02-28 |