Details for New Drug Application (NDA): 208183
✉ Email this page to a colleague
NDA 208183 describes ULTRAVATE, which is a drug marketed by Sun Pharm Inds Inc and Mical Pharms and is included in three NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ULTRAVATE profile page.
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.
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: | 8,962,028 | 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 | ||||||||
Complete Access Available with Subscription
