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Details for New Drug Application (NDA): 022076
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NDA 022076 describes LOCOID, which is a drug marketed by Bausch, Yamanouchi, and Precision Dermat, and is included in eight NDAs. It is available from three suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LOCOID profile page.
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.
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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