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 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.
The generic ingredient in KENALOG-80 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 014901
| Tradename: | KENALOG-80 |
| Applicant: | Apothecon |
| Ingredient: | triamcinolone acetonide |
| Patents: | 0 |
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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