Details for New Drug Application (NDA): 209483
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NDA 209483 describes IMPOYZ, which is a drug marketed by Primus Pharms and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the IMPOYZ profile page.
The generic ingredient in IMPOYZ is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
The generic ingredient in IMPOYZ is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 209483
| Tradename: | IMPOYZ |
| Applicant: | Primus Pharms |
| Ingredient: | clobetasol propionate |
| Patents: | 4 |
Pharmacology for NDA: 209483
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209483
Suppliers and Packaging for NDA: 209483
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMPOYZ | clobetasol propionate | CREAM;TOPICAL | 209483 | NDA | Primus Pharmaceuticals, Inc. | 68040-713 | 68040-713-38 | 1 TUBE in 1 CARTON (68040-713-38) / 100 g in 1 TUBE |
| IMPOYZ | clobetasol propionate | CREAM;TOPICAL | 209483 | NDA | Primus Pharmaceuticals, Inc. | 68040-713 | 68040-713-44 | 20 TUBE in 1 CARTON (68040-713-44) / 2.5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.025% | ||||
| Approval Date: | Nov 28, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 10,064,875 | Patent Expiration: | Aug 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PSORIASIS | ||||||||
| Patent: | 10,064,875 | Patent Expiration: | Aug 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF MODERATE PLAQUE PSORIASIS | ||||||||
| Patent: | 10,064,875 | Patent Expiration: | Aug 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PLAQUE PSORIASIS | ||||||||
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