Application 018086
- Type
- NDA
- Sponsor
- VALEANT PHARMS INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIMOPTIC | TIMOLOL MALEATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.25% BASE | Yes | No |
| 002 | TIMOPTIC | TIMOLOL MALEATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% BASE | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 24208-812 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-812 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-812 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-812 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-812 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-812 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-813 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-813 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-813 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-813 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-813 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-813 | Timoptic | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 68682-812 | Timolol Maleate | Timolol Maleate | Oceanside Pharmaceuticals | NDA | Current |
| 68682-812 | Timolol Maleate | Timolol Maleate | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-812 | Timolol Maleate | Timolol Maleate | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-813 | Timolol Maleate | Timolol Maleate | Oceanside Pharmaceuticals | NDA | Current |
| 68682-813 | Timolol Maleate | Timolol Maleate | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-813 | Timolol Maleate | Timolol Maleate | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 82260-812 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | Current |
| 82260-812 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | Current |
| 82260-813 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | Current |
| 82260-813 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | Current |