Application 021756
- Type
- NDA
- Sponsor
- VALEANT PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MACUGEN | PEGAPTANIB SODIUM | INJECTABLE;INTRAVITREAL | EQ 0.3MG ACID/0.09ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68782-001 | Macugen | pegaptanib sodium | Bausch & Lomb Incorporated | NDA | Current |
| 68782-001 | Macugen | pegaptanib sodium | Bausch Health US, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 16317 | SUPPL | 2011-10-20 |
| 28530 | SUPPL | 2011-10-14 |
| 28529 | SUPPL | 2006-03-23 |
| 37589 | SUPPL | 2006-03-10 |
| 16316 | SUPPL | 2006-03-10 |
| 6128 | SUPPL | 2005-11-18 |
| 6127 | SUPPL | 2005-11-18 |
| 21806 | ORIG | 2005-03-28 |
| 16315 | ORIG | 2004-12-30 |
| 6126 | ORIG | 2004-12-30 |