Application 077200
- Type
- ANDA
- Sponsor
- ALCON PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZADITOR | KETOTIFEN FUMARATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.025% BASE | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0065-4011 | Zaditor | ketotifen fumarate | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-4011 | Zaditor | ketotifen fumarate | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-4011 | Zaditor | ketotifen fumarate | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-4011 | Zaditor | ketotifen fumarate | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-4011 | Zaditor | ketotifen fumarate | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-4011 | Zaditor | ketotifen fumarate | Alcon Laboratories, Inc. | ANDA | Current |
| 0065-4011 | Zaditor | ketotifen fumarate | Alcon Laboratories, Inc. | ANDA | Current |
| 50090-1037 | Zaditor | ketotifen fumarate | A-S Medication Solutions | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43117 | ORIG | 2012-01-27 |