Details for New Drug Application (NDA): 205592
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NDA 205592 describes TRIAMCINOLONE ACETONIDE, which is a drug marketed by Actavis Mid Atlantic, Alkem Labs Ltd, Alpharma Us Pharms, Ambix, Chartwell Rx, Cosette, Encube, Fougera Pharms, Glenmark Pharms Ltd, Macleods Pharms Ltd, Micro Labs, Morton Grove, Norvium Bioscience, Padagis Us, Pharmaderm, Pharmafair, Strides Pharma, Taro, Topiderm, Amneal, Eugia Pharma, Long Grove Pharms, Mylan Labs Ltd, Parnell, Sandoz, Teva Pharms Usa, Watson Labs, Epic Pharma Llc, Pai Holdings Pharm, Quagen, Wockhardt Bio Ag, Aurobindo Pharma Ltd, Cintex Svcs, Glenmark Speclt, Padagis Israel, Rising, Sciegen Pharms Inc, Apotex, and Perrigo Pharma Intl, and is included in ninety-three NDAs. It is available from sixty-one suppliers. Additional details are available on the TRIAMCINOLONE ACETONIDE profile page.
The generic ingredient in TRIAMCINOLONE ACETONIDE is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
The generic ingredient in TRIAMCINOLONE ACETONIDE is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
Summary for 205592
| Tradename: | TRIAMCINOLONE ACETONIDE |
| Applicant: | Cosette |
| Ingredient: | triamcinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 205592
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 205592
Suppliers and Packaging for NDA: 205592
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | triamcinolone acetonide | PASTE;DENTAL | 205592 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0655 | 0713-0655-40 | 1 TUBE in 1 CARTON (0713-0655-40) / 5 g in 1 TUBE |
| TRIAMCINOLONE ACETONIDE | triamcinolone acetonide | PASTE;DENTAL | 205592 | ANDA | Burel Pharmaceuticals, LLC | 35573-404 | 35573-404-54 | 1 TUBE in 1 CARTON (35573-404-54) / 5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | PASTE;DENTAL | Strength | 0.1% | ||||
| Approval Date: | Jan 12, 2017 | TE: | AT | RLD: | No | ||||
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