Details for New Drug Application (NDA): 014901
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NDA 014901 describes KENALOG-80, which is a drug marketed by Apothecon and is included in one NDA. It is available from four suppliers. Additional details are available on the KENALOG-80 profile page.
The generic ingredient in KENALOG-80 is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
The generic ingredient in KENALOG-80 is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
Summary for 014901
| Tradename: | KENALOG-80 |
| Applicant: | Apothecon |
| Ingredient: | triamcinolone acetonide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 014901
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 014901
Suppliers and Packaging for NDA: 014901
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KENALOG-40 | triamcinolone acetonide | INJECTABLE;INJECTION | 014901 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0293 | 0003-0293-05 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-0293-05) / 1 mL in 1 VIAL, SINGLE-DOSE |
| KENALOG-40 | triamcinolone acetonide | INJECTABLE;INJECTION | 014901 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0293 | 0003-0293-20 | 1 VIAL, MULTI-DOSE in 1 CARTON (0003-0293-20) / 5 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/ML | ||||
| Approval Date: | Apr 12, 2019 | TE: | RLD: | Yes | |||||
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