Details for New Drug Application (NDA): 085691
✉ Email this page to a colleague
NDA 085691 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, Sun Pharma Canada, Taro, Topiderm, Alembic, Amneal, Dr Reddys, Eugia Pharma, Hikma, Long Grove Pharms, Mylan Labs Ltd, Parnell, Sandoz, Teva Pharms Usa, Watson Labs, Beach Prods, Epic Pharma Llc, Pai Holdings Pharm, Pharmobedient, Quagen, Aurobindo Pharma Ltd, Extrovis, Glenmark Speclt, Padagis Israel, Senores Pharms, Rising, Sciegen Pharms Inc, Apotex, and Perrigo Pharma Intl, and is included in ninety-seven NDAs. It is available from sixty-eight 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-eight 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-eight 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 Inc. | 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 Inc. | 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 | ||||
Complete Access Available with Subscription
