Details for New Drug Application (NDA): 210209
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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 210209
Tradename: | HYDROCORTISONE BUTYRATE |
Applicant: | Lupin Ltd |
Ingredient: | hydrocortisone butyrate |
Patents: | 0 |
Pharmacology for NDA: 210209
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 210209
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | LOTION;TOPICAL | 210209 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-951 | 68180-951-01 | 1 BOTTLE in 1 CARTON (68180-951-01) / 59 mL in 1 BOTTLE |
HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | LOTION;TOPICAL | 210209 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-951 | 68180-951-02 | 1 BOTTLE in 1 CARTON (68180-951-02) / 118 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.1% | ||||
Approval Date: | Aug 17, 2018 | TE: | AB | RLD: | No |
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