Details for New Drug Application (NDA): 076364
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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 076364
Tradename: | HYDROCORTISONE BUTYRATE |
Applicant: | Taro Pharm Inds |
Ingredient: | hydrocortisone butyrate |
Patents: | 0 |
Pharmacology for NDA: 076364
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076364
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | SOLUTION;TOPICAL | 076364 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4061 | 51672-4061-2 | 1 BOTTLE in 1 CARTON (51672-4061-2) / 20 mL in 1 BOTTLE |
HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | SOLUTION;TOPICAL | 076364 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4061 | 51672-4061-4 | 1 BOTTLE in 1 CARTON (51672-4061-4) / 60 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.1% | ||||
Approval Date: | Jan 14, 2004 | TE: | AT | RLD: | No |
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