Details for New Drug Application (NDA): 209361
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The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 209361
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209361
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209361
Suppliers and Packaging for NDA: 209361
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | clobetasol propionate | SOLUTION;TOPICAL | 209361 | ANDA | Macleods Pharmaceuticals Limited | 33342-321 | 33342-321-39 | 1 BOTTLE in 1 CARTON (33342-321-39) / 25 mL in 1 BOTTLE |
CLOBETASOL PROPIONATE | clobetasol propionate | SOLUTION;TOPICAL | 209361 | ANDA | Macleods Pharmaceuticals Limited | 33342-321 | 33342-321-86 | 1 BOTTLE in 1 CARTON (33342-321-86) / 50 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Oct 25, 2017 | TE: | AT | RLD: | No |
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