Application 212592
- Type
- ANDA
- Sponsor
- IDENTIRX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIMOLOL MALEATE | TIMOLOL MALEATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.25% BASE | No | No |
| 002 | TIMOLOL MALEATE | TIMOLOL MALEATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60940-038 | Timolol Maleate Ophthalmic Solution | Timolol Maleate | Holopack Verpackungstechnik GmbH | ANDA | Current |
| 60940-039 | Timolol Maleate Ophthalmic Solution | Timolol Maleate | Holopack Verpackungstechnik GmbH | ANDA | Current |
| 69918-601 | Timoptic in Ocudose | Timolol Maleate | Amring Pharmaceuticals Inc. | ANDA | Current |
| 69918-602 | Timoptic in Ocudose | Timolol Maleate | Amring Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69850 | ORIG | 2022-01-12 |