Details for New Drug Application (NDA): 072354
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NDA 072354 describes DESOWEN, which is a drug marketed by Galderma Labs Lp and is included in three NDAs. It is available from four suppliers. Additional details are available on the DESOWEN profile page.
The generic ingredient in DESOWEN is desonide. There are thirty-one drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the desonide profile page.
The generic ingredient in DESOWEN is desonide. There are thirty-one drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the desonide profile page.
Summary for 072354
| Tradename: | DESOWEN |
| Applicant: | Galderma Labs Lp |
| Ingredient: | desonide |
| Patents: | 0 |
Pharmacology for NDA: 072354
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 072354
Suppliers and Packaging for NDA: 072354
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESOWEN | desonide | LOTION;TOPICAL | 072354 | ANDA | Galderma Laboratories, L.P. | 0299-5765 | 0299-5765-02 | 59 g in 1 BOTTLE (0299-5765-02) |
| DESOWEN | desonide | LOTION;TOPICAL | 072354 | ANDA | Galderma Laboratories, L.P. | 0299-5765 | 0299-5765-04 | 1 BOTTLE in 1 CARTON (0299-5765-04) / 118 g in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Jan 24, 1992 | TE: | AB | RLD: | No | ||||
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