Details for New Drug Application (NDA): 019048
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NDA 019048 describes DESOWEN, which is a drug marketed by Galderma Labs Lp and is included in three NDAs. It is available from three 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the desonide profile page.
Summary for 019048
| Tradename: | DESOWEN |
| Applicant: | Galderma Labs Lp |
| Ingredient: | desonide |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019048
Suppliers and Packaging for NDA: 019048
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESOWEN | desonide | CREAM;TOPICAL | 019048 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0472-0804 | 0472-0804-15 | 1 TUBE in 1 CARTON (0472-0804-15) / 15 g in 1 TUBE |
| DESOWEN | desonide | CREAM;TOPICAL | 019048 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0472-0804 | 0472-0804-60 | 1 TUBE in 1 CARTON (0472-0804-60) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Dec 14, 1984 | TE: | AB | RLD: | No | ||||
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