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 two suppliers. There is one patent 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. Six 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. Six 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: | 1 |
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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | LOTION;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | May 18, 2007 | TE: | RLD: | Yes | |||||
| Patent: | 7,981,877 | Patent Expiration: | Jan 23, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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