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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209269

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MINOLIRA (MINOCYCLINE HYDROCHLORIDE)
EQ 105MG BASE
Marketing Status: Prescription
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOLIRA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 105MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N209269
Product Number: 001
Approval Date: May 8, 2017
Applicant Holder Full Name: EPI HEALTH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MINOLIRA (MINOCYCLINE HYDROCHLORIDE)
EQ 135MG BASE
Marketing Status: Prescription
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOLIRA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 135MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: N209269
Product Number: 002
Approval Date: May 8, 2017
Applicant Holder Full Name: EPI HEALTH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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