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Application 022048
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRIESENCE | TRIAMCINOLONE ACETONIDE | INJECTABLE;INTRAVITREAL | 40MG/ML (40MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0065-0543 | TRIESENCE | triamcinolone acetonide | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0543 | TRIESENCE | triamcinolone acetonide | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0543 | TRIESENCE | triamcinolone acetonide | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0543 | TRIESENCE | triamcinolone acetonide | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0543 | TRIESENCE | triamcinolone acetonide | Alcon Laboratories, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 42401 | ORIG | 2008-07-08 |
| 6771 | ORIG | 2008-01-09 |
| 38146 | ORIG | 2007-12-03 |
| 53427 | ORIG | 1900-01-01 |
| 53426 | ORIG | 1900-01-01 |
| 53425 | ORIG | 1900-01-01 |