Details for New Drug Application (NDA): 213291
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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 213291
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Alembic |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213291
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 213291
Suppliers and Packaging for NDA: 213291
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | clobetasol propionate | CREAM;TOPICAL | 213291 | ANDA | Alembic Pharmaceuticals Inc. | 62332-547 | 62332-547-15 | 1 TUBE in 1 CARTON (62332-547-15) / 15 g in 1 TUBE |
CLOBETASOL PROPIONATE | clobetasol propionate | CREAM;TOPICAL | 213291 | ANDA | Alembic Pharmaceuticals Inc. | 62332-547 | 62332-547-30 | 1 TUBE in 1 CARTON (62332-547-30) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Jan 27, 2020 | TE: | AB1 | RLD: | No |
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