Details for New Drug Application (NDA): 217671
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NDA 217671 describes HALCINONIDE, which is a drug marketed by Chartwell Rx, Mylan, and Encube, and is included in three NDAs. It is available from two 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the halcinonide profile page.
Summary for 217671
| Tradename: | HALCINONIDE |
| Applicant: | Encube |
| Ingredient: | halcinonide |
| Patents: | 0 |
Pharmacology for NDA: 217671
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 217671
Suppliers and Packaging for NDA: 217671
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALCINONIDE | halcinonide | SOLUTION;TOPICAL | 217671 | ANDA | Encube Ethicals Private Limited | 21922-069 | 21922-069-52 | 1 BOTTLE, PLASTIC in 1 CARTON (21922-069-52) / 120 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | May 29, 2024 | TE: | RLD: | No | |||||
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