Details for New Drug Application (NDA): 022048
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The generic ingredient in TRIESENCE is triamcinolone acetonide. There is one drug master file entry for this compound. Eighty suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
Summary for 022048
| Tradename: | TRIESENCE |
| Applicant: | Harrow Eye |
| Ingredient: | triamcinolone acetonide |
| Patents: | 2 |
Pharmacology for NDA: 022048
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 022048
Suppliers and Packaging for NDA: 022048
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIESENCE | triamcinolone acetonide | INJECTABLE;INTRAVITREAL | 022048 | NDA | Novartis Pharmaceuticals Corporation | 0078-0897 | 0078-0897-78 | 1 BLISTER PACK in 1 CARTON (0078-0897-78) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS |
| TRIESENCE | triamcinolone acetonide | INJECTABLE;INTRAVITREAL | 022048 | NDA | Harrow Eye, LLC | 82667-800 | 82667-800-01 | 1 BLISTER PACK in 1 CARTON (82667-800-01) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVITREAL | Strength | 40MG/ML (40MG/ML) | ||||
| Approval Date: | Nov 29, 2007 | TE: | RLD: | Yes | |||||
| Patent: | 8,128,960 | Patent Expiration: | Dec 17, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,211,880 | Patent Expiration: | Mar 10, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF OPHTHALMIC DISORDERS | ||||||||
| Patent: | 8,211,880 | Patent Expiration: | Mar 10, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | VISUALIZATION DURING VITRECTOMY PROCEDURES | ||||||||
Expired US Patents for NDA 022048
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Harrow Eye | TRIESENCE | triamcinolone acetonide | INJECTABLE;INTRAVITREAL | 022048-001 | Nov 29, 2007 | 6,395,294 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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