Application 204706
- Type
- ANDA
- Sponsor
- ZAMBON SPA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.1% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68788-6317 | Olopatadine Hydrochloride | Olopatadine Hydrochloride 0.1% | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7403 | Olopatadine Hydrochloride | Olopatadine Hydrochloride 0.1% | Preferred Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10381 | ORIG | 2015-12-09 |