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Details for New Drug Application (NDA): 022076
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The generic ingredient in LOCOID is hydrocortisone butyrate. There are sixty-seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.
Summary for 022076
Tradename: | LOCOID |
Applicant: | Bausch |
Ingredient: | hydrocortisone butyrate |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022076
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 022076
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOCOID | hydrocortisone butyrate | LOTION;TOPICAL | 022076 | NDA | Bausch Health US LLC | 16781-392 | 16781-392-02 | 1 BOTTLE in 1 CARTON (16781-392-02) > 59 mL in 1 BOTTLE |
LOCOID | hydrocortisone butyrate | LOTION;TOPICAL | 022076 | NDA | Bausch Health US LLC | 16781-392 | 16781-392-04 | 1 BOTTLE in 1 CARTON (16781-392-04) > 118 mL in 1 BOTTLE |
Paragraph IV (Patent) Challenges for 022076
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
LOCOID | LOTION;TOPICAL | hydrocortisone butyrate | 022076 | 2016-08-31 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.1% | ||||
Approval Date: | May 18, 2007 | TE: | AB | RLD: | Yes | ||||
Patent: | Start Trial | Patent Expiration: | Dec 19, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Jan 23, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? |
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