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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 201922


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NDA 201922 describes XIMINO, which is a drug marketed by Journey and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the XIMINO profile page.

The generic ingredient in XIMINO is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 201922
Tradename:XIMINO
Applicant:Journey
Ingredient:minocycline hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 201922
Physiological EffectDecreased Prothrombin Activity
Medical Subject Heading (MeSH) Categories for 201922
Suppliers and Packaging for NDA: 201922
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922 NDA Journey Medical Corporation 69489-121 69489-121-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69489-121-30)
XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922 NDA Journey Medical Corporation 69489-122 69489-122-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69489-122-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE
Approval Date:Jul 11, 2012TE:RLD:No
Patent:⤷  Try a TrialPatent Expiration:Apr 2, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Patent:⤷  Try a TrialPatent Expiration:Apr 2, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

Expired US Patents for NDA 201922

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-001 Jul 11, 2012 ⤷  Try a Trial ⤷  Try a Trial
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-003 Jul 11, 2012 ⤷  Try a Trial ⤷  Try a Trial
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-005 Jul 11, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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