Details for New Drug Application (NDA): 209535
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The generic ingredient in TRIAMCINOLONE ACETONIDE 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 209535
Tradename: | TRIAMCINOLONE ACETONIDE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | triamcinolone acetonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209535
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209535
Suppliers and Packaging for NDA: 209535
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRIAMCINOLONE ACETONIDE | triamcinolone acetonide | CREAM;TOPICAL | 209535 | ANDA | NorthStar RxLLC | 16714-985 | 16714-985-01 | 1 TUBE in 1 CARTON (16714-985-01) / 15 g in 1 TUBE |
TRIAMCINOLONE ACETONIDE | triamcinolone acetonide | CREAM;TOPICAL | 209535 | ANDA | NorthStar RxLLC | 16714-985 | 16714-985-02 | 1 TUBE in 1 CARTON (16714-985-02) / 80 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.025% | ||||
Approval Date: | May 18, 2018 | TE: | AT | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
Approval Date: | May 18, 2018 | TE: | AT | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.5% | ||||
Approval Date: | May 18, 2018 | TE: | AT | RLD: | No |
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