Application 020330
- Type
- NDA
- Sponsor
- VALEANT PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIMOPTIC-XE | TIMOLOL MALEATE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | EQ 0.25% BASE | Yes | Yes |
| 002 | TIMOPTIC-XE | TIMOLOL MALEATE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | EQ 0.5% BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 24208-814 | Timoptic-XE | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-814 | Timoptic-XE | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-814 | Timoptic-XE | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-814 | Timoptic-XE | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-816 | Timoptic-XE | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-816 | Timoptic-XE | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-816 | Timoptic-XE | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-816 | Timoptic-XE | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-818 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Incorporated | NDA AUTHORIZED GENERIC | Current |
| 24208-818 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Incorporated | NDA AUTHORIZED GENERIC | Current |
| 24208-819 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Incorporated | NDA AUTHORIZED GENERIC | Current |
| 24208-819 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Incorporated | NDA AUTHORIZED GENERIC | Current |
| 82260-818 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | Current |
| 82260-818 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | Current |
| 82260-819 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | Current |
| 82260-819 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | Current |