Details for New Drug Application (NDA): 077001
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NDA 077001 describes HALOBETASOL PROPIONATE, which is a drug marketed by Padagis Israel, Cosette, Fougera Pharms, Taro, Encube, and Quagen, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the HALOBETASOL PROPIONATE profile page.
The generic ingredient in HALOBETASOL PROPIONATE is halobetasol propionate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
The generic ingredient in HALOBETASOL PROPIONATE is halobetasol propionate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
Summary for 077001
| Tradename: | HALOBETASOL PROPIONATE |
| Applicant: | Fougera Pharms |
| Ingredient: | halobetasol propionate |
| Patents: | 0 |
Pharmacology for NDA: 077001
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 077001
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALOBETASOL PROPIONATE | halobetasol propionate | CREAM;TOPICAL | 077001 | ANDA | Fougera Pharmaceuticals Inc. | 0168-0355 | 0168-0355-50 | 50 g in 1 TUBE (0168-0355-50) |
| HALOBETASOL PROPIONATE | halobetasol propionate | CREAM;TOPICAL | 077001 | ANDA | Bryant Ranch Prepack | 63629-8735 | 63629-8735-1 | 15 g in 1 TUBE (63629-8735-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Dec 16, 2004 | TE: | AB | RLD: | No | ||||
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