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Last Updated: May 21, 2024

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.
Summary for 212379
Tradename:AMZEEQ
Applicant:Journey
Ingredient:minocycline hydrochloride
Patents:12
Formulation / Manufacturing:see details
Pharmacology for NDA: 212379
Physiological EffectDecreased 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:RXDosage:AEROSOL, FOAM;TOPICALStrengthEQ 4% BASE
Approval Date:Oct 18, 2019TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 1, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-NODULAR ACNE VULGARIS
Patent:⤷  Try a TrialPatent Expiration:Oct 1, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-NODULAR ACNE VULGARIS
Patent:⤷  Try a TrialPatent Expiration:Oct 1, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF NON-NODULAR ACNE VULGARIS

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