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Details for New Drug Application (NDA): 022076
NDA 022076 describes LOCOID, which is a drug marketed by Precision Dermat and Yamanouchi and is included in eight NDAs. It is available from two 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-four drug master file entries for this compound. Seven 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-four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.
Summary for 022076
| Tradename: | LOCOID |
| Applicant: | Precision Dermat |
| Ingredient: | hydrocortisone butyrate |
| Patents: | 2 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) |
| 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 | Onset Dermatologics, LLC | 16781-392 | N | 16781-392-04 |
| LOCOID | hydrocortisone butyrate | LOTION;TOPICAL | 022076 | NDA | Onset Dermatologics, LLC | 16781-392 | N | 16781-392-06 |
Profile for product number 001
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