Details for New Drug Application (NDA): 207133
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NDA 207133 describes FLURANDRENOLIDE, which is a drug marketed by Chartwell Rx, Alpharma Us Pharms, Padagis Israel, and Teligent, and is included in five NDAs. It is available from two suppliers. Additional details are available on the FLURANDRENOLIDE profile page.
The generic ingredient in FLURANDRENOLIDE is flurandrenolide. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the flurandrenolide profile page.
The generic ingredient in FLURANDRENOLIDE is flurandrenolide. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the flurandrenolide profile page.
Summary for 207133
| Tradename: | FLURANDRENOLIDE |
| Applicant: | Padagis Israel |
| Ingredient: | flurandrenolide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207133
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 207133
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLURANDRENOLIDE | flurandrenolide | LOTION;TOPICAL | 207133 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-928 | 45802-928-03 | 120 mL in 1 BOTTLE, PLASTIC (45802-928-03) |
| FLURANDRENOLIDE | flurandrenolide | LOTION;TOPICAL | 207133 | ANDA | Bryant Ranch Prepack | 63629-8657 | 63629-8657-1 | 1 BOTTLE, PLASTIC in 1 CARTON (63629-8657-1) / 120 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Aug 30, 2016 | TE: | RLD: | No | |||||
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