Details for New Drug Application (NDA): 212379
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NDA 212379 describes AMZEEQ, which is a drug marketed by Journey and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the AMZEEQ profile page.
The generic ingredient in AMZEEQ is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
The generic ingredient in AMZEEQ is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 212379
| Tradename: | AMZEEQ |
| Applicant: | Journey |
| Ingredient: | minocycline hydrochloride |
| Patents: | 12 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212379
| Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for 212379
Suppliers and Packaging for NDA: 212379
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMZEEQ | minocycline hydrochloride | AEROSOL, FOAM;TOPICAL | 212379 | NDA | Journey Medical Corporation | 69489-201 | 69489-201-03 | 1 CAN in 1 CARTON (69489-201-03) / 3 g in 1 CAN |
| AMZEEQ | minocycline hydrochloride | AEROSOL, FOAM;TOPICAL | 212379 | NDA | Journey Medical Corporation | 69489-201 | 69489-201-30 | 1 CAN in 1 CARTON (69489-201-30) / 30 g in 1 CAN |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | EQ 4% BASE | ||||
| Approval Date: | Oct 18, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 1, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF NON-NODULAR ACNE VULGARIS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 1, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF NON-NODULAR ACNE VULGARIS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 1, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF NON-NODULAR ACNE VULGARIS | ||||||||
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