Details for New Drug Application (NDA): 208841
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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 208841
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Novel Labs Inc |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208841
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 208841
Suppliers and Packaging for NDA: 208841
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | clobetasol propionate | OINTMENT;TOPICAL | 208841 | ANDA | Novel Laboratories, Inc. | 40032-096 | 40032-096-60 | 1 TUBE in 1 CARTON (40032-096-60) / 15 g in 1 TUBE |
CLOBETASOL PROPIONATE | clobetasol propionate | OINTMENT;TOPICAL | 208841 | ANDA | Novel Laboratories, Inc. | 40032-096 | 40032-096-61 | 1 TUBE in 1 CARTON (40032-096-61) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.05% | ||||
Approval Date: | May 4, 2018 | TE: | AB | RLD: | No |
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