Details for New Drug Application (NDA): 021835
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The generic ingredient in CLOBEX is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 021835
| Tradename: | CLOBEX |
| Applicant: | Galderma Labs Lp |
| Ingredient: | clobetasol propionate |
| Patents: | 0 |
Pharmacology for NDA: 021835
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 021835
Suppliers and Packaging for NDA: 021835
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835 | NDA | Galderma Laboratories, L.P. | 0299-3849 | 0299-3849-01 | 1 BOTTLE in 1 CARTON (0299-3849-01) / 10 mL in 1 BOTTLE |
| CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835 | NDA | Galderma Laboratories, L.P. | 0299-3849 | 0299-3849-02 | 1 BOTTLE in 1 CARTON (0299-3849-02) / 59 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Oct 27, 2005 | TE: | AT | RLD: | Yes | ||||
Expired US Patents for NDA 021835
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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