Details for New Drug Application (NDA): 018594
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NDA 018594 describes TOPICORT, which is a drug marketed by Taro and Sun Pharma Canada and is included in ten NDAs. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TOPICORT profile page.
The generic ingredient in TOPICORT is desoximetasone. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.
The generic ingredient in TOPICORT is desoximetasone. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.
Summary for 018594
| Tradename: | TOPICORT |
| Applicant: | Taro |
| Ingredient: | desoximetasone |
| Patents: | 0 |
Pharmacology for NDA: 018594
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 018594
Suppliers and Packaging for NDA: 018594
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOPICORT | desoximetasone | OINTMENT;TOPICAL | 018594 | NDA | Sun Pharmaceutical Industries, Inc. | 51672-1352 | 51672-1352-1 | 1 TUBE in 1 CARTON (51672-1352-1) / 15 g in 1 TUBE |
| TOPICORT | desoximetasone | OINTMENT;TOPICAL | 018594 | NDA | Sun Pharmaceutical Industries, Inc. | 51672-1352 | 51672-1352-2 | 1 TUBE in 1 CARTON (51672-1352-2) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Jan 17, 1985 | TE: | AB | RLD: | Yes | ||||
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