Details for New Drug Application (NDA): 085691
NDA 085691 describes TRIAMCINOLONE ACETONIDE, which is a drug marketed by Actavis Mid Atlantic, Alkem Labs Ltd, Alpharma Us Pharms, Ambix, Chartwell Rx, Cosette Pharms Nc, Encube, Fougera Pharms, Glenmark Pharms Ltd, Macleods Pharms, Micro Labs, Morton Grove, Padagis Us, Pharmaderm, Pharmafair, Pharmobedient, Strides Pharma, Sun Pharma Canada, Taro, Topiderm, Alembic, Amneal, Caplin, Dr Reddys, Eugia Pharma, Hikma, Long Grove Pharms, Mylan Labs Ltd, Parnell, Sandoz, Teva Pharms Usa, Watson Labs, Beach Prods, Epic Pharma Llc, Quagen, Aurobindo Pharma Ltd, Extrovis, Glenmark Speclt, Padagis Israel, Pharmazone, Rising, Sciegen Pharms, Apotex, and Perrigo Pharma Intl, and is included in ninety-eight NDAs. It is available from seventy suppliers. Additional details are available on the TRIAMCINOLONE ACETONIDE profile page.
The generic ingredient in TRIAMCINOLONE ACETONIDE 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 TRIAMCINOLONE ACETONIDE 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 085691
| Tradename: | TRIAMCINOLONE ACETONIDE |
| Applicant: | Fougera Pharms |
| Ingredient: | triamcinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 085691
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 085691
Suppliers and Packaging for NDA: 085691
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | triamcinolone acetonide | OINTMENT;TOPICAL | 085691 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0005 | 0168-0005-80 | 80 g in 1 TUBE (0168-0005-80) |
| TRIAMCINOLONE ACETONIDE | triamcinolone acetonide | OINTMENT;TOPICAL | 085691 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0006 | 0168-0006-15 | 15 g in 1 TUBE (0168-0006-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.025% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.5% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
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