Details for New Drug Application (NDA): 213690
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NDA 213690 describes ZILXI, which is a drug marketed by Journey and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ZILXI profile page.
The generic ingredient in ZILXI is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
The generic ingredient in ZILXI is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 213690
| Tradename: | ZILXI |
| Applicant: | Journey |
| Ingredient: | minocycline hydrochloride |
| Patents: | 8 |
Pharmacology for NDA: 213690
| Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for 213690
Suppliers and Packaging for NDA: 213690
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZILXI | minocycline hydrochloride | AEROSOL, FOAM;TOPICAL | 213690 | NDA | Journey Medical Corporation | 69489-212 | 69489-212-03 | 1 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CAN |
| ZILXI | minocycline hydrochloride | AEROSOL, FOAM;TOPICAL | 213690 | NDA | Journey Medical Corporation | 69489-212 | 69489-212-30 | 1 CAN in 1 CARTON (69489-212-30) / 30 g in 1 CAN |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | EQ 1.5% BASE | ||||
| Approval Date: | May 28, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Oct 1, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA. | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Oct 1, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Oct 1, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA. | ||||||||
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