Application 090918
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.2% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-0586 | Olopatadine Hydrochloride | Olopatadine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0586 | Olopatadine Hydrochloride | Olopatadine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0586 | Olopatadine Hydrochloride | Olopatadine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-6222 | Olopatadine hydrochloride | Olopatadine hydrochloride | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 50990 | ORIG | 2018-01-08 |