Details for New Drug Application (NDA): 088042
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NDA 088042 describes TRIDERM, which is a drug marketed by Crown Labs and is included in one NDA. It is available from thirteen suppliers. Additional details are available on the TRIDERM profile page.
The generic ingredient in TRIDERM is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
The generic ingredient in TRIDERM is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
Summary for 088042
| Tradename: | TRIDERM |
| Applicant: | Crown Labs |
| Ingredient: | triamcinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 088042
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 088042
Suppliers and Packaging for NDA: 088042
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIDERM | triamcinolone acetonide | CREAM;TOPICAL | 088042 | ANDA | Crown Laboratories | 0316-0165 | 0316-0165-15 | 1 TUBE in 1 CARTON (0316-0165-15) / 15 g in 1 TUBE |
| TRIDERM | triamcinolone acetonide | CREAM;TOPICAL | 088042 | ANDA | Crown Laboratories | 0316-0165 | 0316-0165-16 | 1 JAR in 1 CARTON (0316-0165-16) / 454 g in 1 JAR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Mar 19, 1984 | TE: | AT | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.025% | ||||
| Approval Date: | Mar 25, 2015 | TE: | AT | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.5% | ||||
| Approval Date: | Mar 25, 2015 | TE: | AT | RLD: | No | ||||
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