Details for New Drug Application (NDA): 206075
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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 206075
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Novel Labs Inc |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206075
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 206075
Suppliers and Packaging for NDA: 206075
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | clobetasol propionate | SOLUTION;TOPICAL | 206075 | ANDA | Novel Laboratories, Inc. | 40032-028 | 40032-028-60 | 1 BOTTLE in 1 CARTON (40032-028-60) / 50 mL in 1 BOTTLE |
CLOBETASOL PROPIONATE | clobetasol propionate | SOLUTION;TOPICAL | 206075 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-028 | 43386-028-60 | 1 BOTTLE in 1 CARTON (43386-028-60) / 50 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Nov 23, 2015 | TE: | AT | RLD: | No |
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