Details for New Drug Application (NDA): 214723
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NDA 214723 describes HALCINONIDE, which is a drug marketed by Chartwell Rx, Mylan, and Encube, and is included in three NDAs. It is available from three suppliers. Additional details are available on the HALCINONIDE profile page.
The generic ingredient in HALCINONIDE is halcinonide. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the halcinonide profile page.
The generic ingredient in HALCINONIDE is halcinonide. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the halcinonide profile page.
Summary for 214723
| Tradename: | HALCINONIDE |
| Applicant: | Chartwell Rx |
| Ingredient: | halcinonide |
| Patents: | 0 |
Pharmacology for NDA: 214723
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 214723
Suppliers and Packaging for NDA: 214723
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALCINONIDE | halcinonide | CREAM;TOPICAL | 214723 | ANDA | Glasshouse Pharmaceuticals Limited Canada | 71428-011 | 71428-011-30 | 1 TUBE in 1 CARTON (71428-011-30) / 30 g in 1 TUBE |
| HALCINONIDE | halcinonide | CREAM;TOPICAL | 214723 | ANDA | Glasshouse Pharmaceuticals Limited Canada | 71428-011 | 71428-011-60 | 1 TUBE in 1 CARTON (71428-011-60) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Sep 8, 2021 | TE: | AB | RLD: | No | ||||
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