Details for New Drug Application (NDA): 076654
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The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. There are sixty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.
Summary for 076654
Tradename: | HYDROCORTISONE BUTYRATE |
Applicant: | Taro Pharm Inds |
Ingredient: | hydrocortisone butyrate |
Patents: | 0 |
Pharmacology for NDA: 076654
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076654
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | CREAM;TOPICAL | 076654 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074 | 51672-4074-1 | 1 TUBE in 1 CARTON (51672-4074-1) / 15 g in 1 TUBE |
HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | CREAM;TOPICAL | 076654 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074 | 51672-4074-2 | 1 TUBE in 1 CARTON (51672-4074-2) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
Approval Date: | Aug 3, 2005 | TE: | AB1 | RLD: | No |
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