Details for New Drug Application (NDA): 215266
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NDA 215266 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 215266
| Tradename: | HALOBETASOL PROPIONATE |
| Applicant: | Padagis Israel |
| Ingredient: | halobetasol propionate |
| Patents: | 0 |
Pharmacology for NDA: 215266
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 215266
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALOBETASOL PROPIONATE | halobetasol propionate | AEROSOL, FOAM;TOPICAL | 215266 | ANDA | Mayne Pharma | 68308-769 | 68308-769-50 | 1 CANISTER in 1 CARTON (68308-769-50) / 50 g in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Aug 11, 2023 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jun 24, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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