Application 208582
- Type
- NDA
- Sponsor
- ALTAIRE PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ALTAFLUOR BENOX | BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM | SOLUTION/DROPS;OPHTHALMIC | 0.4%;0.25% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59390-218 | ALTAFLUOR | Fluorescein Sodium and Benoxinate Hydrochloride | Altaire Pharmaceuticals Inc. | NDA | Current |
| 59390-218 | ALTAFLUOR | Fluorescein Sodium and Benoxinate Hydrochloride | Altaire Pharmaceuticals Inc. | NDA | Current |
| 59390-218 | ALTAFLUOR | Fluorescein Sodium and Benoxinate Hydrochloride | Altaire Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53641 | ORIG | 2018-04-09 |
| 53469 | ORIG | 2018-03-28 |
| 50779 | ORIG | 2017-12-20 |