Details for New Drug Application (NDA): 018849
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NDA 018849 describes LIDEX, which is a drug marketed by Alvogen and is included in three NDAs. It is available from two suppliers. Additional details are available on the LIDEX profile page.
The generic ingredient in LIDEX is fluocinonide. There are nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.
The generic ingredient in LIDEX is fluocinonide. There are nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.
Summary for 018849
| Tradename: | LIDEX |
| Applicant: | Alvogen |
| Ingredient: | fluocinonide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018849
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 018849
Suppliers and Packaging for NDA: 018849
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDEX | fluocinonide | SOLUTION;TOPICAL | 018849 | NDA | Alvogen Inc. | 47781-602 | 47781-602-26 | 1 BOTTLE, PLASTIC in 1 CARTON (47781-602-26) / 60 mL in 1 BOTTLE, PLASTIC |
| LIDEX | fluocinonide | SOLUTION;TOPICAL | 018849 | NDA | Alvogen Inc. | 47781-602 | 47781-602-49 | 1 BOTTLE, PLASTIC in 1 CARTON (47781-602-49) / 20 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Apr 6, 1984 | TE: | AT | RLD: | Yes | ||||
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