Application 019463
- Type
- NDA
- Sponsor
- VALEANT PHARMS INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIMOPTIC IN OCUDOSE | TIMOLOL MALEATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.25% BASE | Yes | Yes |
| 002 | TIMOPTIC IN OCUDOSE | TIMOLOL MALEATE | SOLUTION/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 |
|---|
| 0187-1496 | Timoptic in Ocudose | Timolol Maleate | Bausch Health Americas Inc. | NDA | Current |
| 0187-1496 | Timoptic in Ocudose | Timolol Maleate | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-1496 | Timoptic in Ocudose | Timolol Maleate | Bausch Health US LLC | NDA | Current |
| 0187-1496 | Timoptic in Ocudose | Timolol Maleate | Bausch Health US LLC | NDA | Current |
| 0187-1496 | Timoptic in Ocudose | Timolol Maleate | Bausch Health US LLC | NDA | Current |
| 0187-1498 | Timoptic in Ocudose | Timolol Maleate | Bausch Health Americas Inc. | NDA | Current |
| 0187-1498 | Timoptic in Ocudose | Timolol Maleate | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-1498 | Timoptic in Ocudose | Timolol Maleate | Bausch Health US LLC | NDA | Current |
| 0187-1498 | Timoptic in Ocudose | Timolol Maleate | Bausch Health US LLC | NDA | Current |
| 0187-1498 | Timoptic in Ocudose | Timolol Maleate | Bausch Health US LLC | NDA | Current |
| 24208-496 | Timolol Maleate | Timolol Maleate | BAUSCH & LOMB INCORPORATED | NDA AUTHORIZED GENERIC | Current |
| 24208-498 | Timoptic in Ocudose | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-499 | Timoptic in Ocudose | Timolol Maleate | Bausch & Lomb Incorporated | NDA | Current |
| 25010-814 | Timoptic | Timolol Maleate | Aton Pharma, Inc. | NDA | Current |
| 25010-815 | Timoptic | Timolol Maleate | Aton Pharma, Inc. | NDA | Current |
| 82260-496 | Timolol Maleate | Timolol Maleate | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 47975 | SUPPL | 2017-04-12 |
| 47893 | SUPPL | 2017-04-07 |
| 17412 | SUPPL | 2011-10-03 |
| 33758 | SUPPL | 2011-09-30 |
| 1335 | SUPPL | 2006-06-08 |
| 33757 | SUPPL | 2006-06-06 |
| 20248 | SUPPL | 2006-05-08 |
| 33756 | SUPPL | 2003-12-29 |
| 1334 | SUPPL | 2003-12-24 |
| 20247 | SUPPL | 2003-09-11 |
| 33755 | SUPPL | 2003-04-15 |