Application 208158
- Type
- ANDA
- Sponsor
- BAUSCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALAWAY | KETOTIFEN FUMARATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.035% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24208-600 | Alaway Preservative Free | ketotifen fumarate | Bausch & Lomb Incorporated | ANDA | Current |
| 24208-600 | Alaway Preservative Free | ketotifen fumarate | Bausch & Lomb Incorporated | ANDA | Current |
| 24208-600 | Alaway Preservative Free | ketotifen fumarate | Bausch & Lomb Incorporated | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65090 | ORIG | 2020-10-30 |