Application 204059
- Type
- ANDA
- Sponsor
- BAYSHORE PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.025% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 76385-106 | Ketotifen Fumarate | Ketotifen Fumarate | Bayshore Pharmaceuticals, LLC | ANDA | Current |