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-five 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 |
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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