Details for New Drug Application (NDA): 089472
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NDA 089472 describes U-CORT, which is a drug marketed by Taro and is included in one NDA. It is available from one supplier. Additional details are available on the U-CORT profile page.
The generic ingredient in U-CORT is hydrocortisone acetate. There are sixty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
The generic ingredient in U-CORT is hydrocortisone acetate. There are sixty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
Summary for 089472
| Tradename: | U-CORT |
| Applicant: | Taro |
| Ingredient: | hydrocortisone acetate |
| Patents: | 0 |
Pharmacology for NDA: 089472
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 089472
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| U-CORT | hydrocortisone acetate | CREAM;TOPICAL | 089472 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-3009 | 51672-3009-2 | 1 TUBE in 1 CARTON (51672-3009-2) / 28.35 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Jun 13, 1988 | TE: | RLD: | No | |||||
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