Details for New Drug Application (NDA): 202145
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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 202145
Tradename: | HYDROCORTISONE BUTYRATE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | hydrocortisone butyrate |
Patents: | 0 |
Pharmacology for NDA: 202145
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 202145
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | CREAM;TOPICAL | 202145 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-464 | 68462-464-17 | 15 g in 1 CARTON (68462-464-17) |
HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | CREAM;TOPICAL | 202145 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-464 | 68462-464-47 | 45 g in 1 CARTON (68462-464-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
Approval Date: | Sep 27, 2013 | TE: | AB2 | RLD: | No |
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