Product Details for NDA 201922
XIMINO (MINOCYCLINE HYDROCHLORIDE)
EQ 45MG BASE
Marketing Status: Discontinued
EQ 67.5MG BASE
Marketing Status: Discontinued
EQ 90MG BASE
Marketing Status: Discontinued
EQ 112.5MG BASE
Marketing Status: Discontinued
EQ 135MG BASE
Marketing Status: Discontinued
EQ 45MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 45MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 001
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
XIMINO (MINOCYCLINE HYDROCHLORIDE)
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 45MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 001
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 67.5MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 67.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 002
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
XIMINO (MINOCYCLINE HYDROCHLORIDE)
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 67.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 002
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 90MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 90MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 003
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
XIMINO (MINOCYCLINE HYDROCHLORIDE)
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 90MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 003
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 112.5MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 112.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 004
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
XIMINO (MINOCYCLINE HYDROCHLORIDE)
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 112.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 004
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 135MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 135MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 005
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: XIMINO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 135MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N201922
Product Number: 005
Approval Date: Jul 11, 2012
Applicant Holder Full Name: JOURNEY MEDICAL CORP
Marketing Status: Discontinued
Patent and Exclusivity Information