Details for New Drug Application (NDA): 209361
✉ Email this page to a colleague
The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Thirty-nine 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 |
Complete Access Available with Subscription