Details for New Drug Application (NDA): 208183
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The generic ingredient in ULTRAVATE 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 208183
Tradename: | ULTRAVATE |
Applicant: | Mical Pharms |
Ingredient: | halobetasol propionate |
Patents: | 1 |
Pharmacology for NDA: 208183
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208183
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ULTRAVATE | halobetasol propionate | LOTION;TOPICAL | 208183 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-122 | 10631-122-04 | 59 g in 1 BOTTLE (10631-122-04) |
ULTRAVATE | halobetasol propionate | LOTION;TOPICAL | 208183 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-122 | 10631-122-51 | 2 BOTTLE in 1 CARTON (10631-122-51) / 59 g in 1 BOTTLE (10631-122-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | LOTION;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Nov 6, 2015 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 19, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE OF A LOTION CONTAINING HALOBETASOL PROPIONATE FOR THE TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES INCLUDING PSORIASIS |
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