Details for New Drug Application (NDA): 219015
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NDA 219015 describes EMROSI, which is a drug marketed by Journey and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the EMROSI profile page.
The generic ingredient in EMROSI is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
The generic ingredient in EMROSI is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 219015
| Tradename: | EMROSI |
| Applicant: | Journey |
| Ingredient: | minocycline hydrochloride |
| Patents: | 3 |
Pharmacology for NDA: 219015
| Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for 219015
Suppliers and Packaging for NDA: 219015
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMROSI | minocycline hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 219015 | NDA | Journey Medical Corporation | 69489-131 | 69489-131-07 | 7 CAPSULE in 1 BOTTLE (69489-131-07) |
| EMROSI | minocycline hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 219015 | NDA | Journey Medical Corporation | 69489-131 | 69489-131-30 | 30 CAPSULE in 1 BOTTLE (69489-131-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Nov 1, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 1, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,905,664 | Patent Expiration: | Jan 7, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | EMROSI IS INDICATED TO TREAT INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA IN ADULTS | ||||||||
| Patent: | 11,191,740 | Patent Expiration: | Jan 7, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | EMROSI IS INDICATED TO TREAT INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA IN ADULTS | ||||||||
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