Details for New Drug Application (NDA): 211027
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NDA 211027 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 211027
| Tradename: | HALCINONIDE |
| Applicant: | Mylan |
| Ingredient: | halcinonide |
| Patents: | 0 |
Pharmacology for NDA: 211027
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 211027
Suppliers and Packaging for NDA: 211027
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALCINONIDE | halcinonide | CREAM;TOPICAL | 211027 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8056 | 0378-8056-49 | 1 TUBE in 1 CARTON (0378-8056-49) / 30 g in 1 TUBE |
| HALCINONIDE | halcinonide | CREAM;TOPICAL | 211027 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8056 | 0378-8056-60 | 1 TUBE in 1 CARTON (0378-8056-60) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Aug 12, 2019 | TE: | AB | RLD: | No | ||||
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