Details for New Drug Application (NDA): 078162
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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 078162
Tradename: | HALOBETASOL PROPIONATE |
Applicant: | Cosette |
Ingredient: | halobetasol propionate |
Patents: | 0 |
Pharmacology for NDA: 078162
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 078162
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOBETASOL PROPIONATE | halobetasol propionate | CREAM;TOPICAL | 078162 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0640 | 0713-0640-15 | 15 g in 1 TUBE (0713-0640-15) |
HALOBETASOL PROPIONATE | halobetasol propionate | CREAM;TOPICAL | 078162 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0640 | 0713-0640-86 | 50 g in 1 TUBE (0713-0640-86) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Apr 24, 2007 | TE: | AB | RLD: | No |
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