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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021164

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EXXUA (GEPIRONE HYDROCHLORIDE)
EQ 18.2MG BASE
Marketing Status: Prescription
Active Ingredient: GEPIRONE HYDROCHLORIDE
Proprietary Name: EXXUA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 18.2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021164
Product Number: 001
Approval Date: Sep 22, 2023
Applicant Holder Full Name: FABRE KRAMER PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
EXXUA (GEPIRONE HYDROCHLORIDE)
EQ 36.3MG BASE
Marketing Status: Prescription
Active Ingredient: GEPIRONE HYDROCHLORIDE
Proprietary Name: EXXUA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 36.3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021164
Product Number: 002
Approval Date: Sep 22, 2023
Applicant Holder Full Name: FABRE KRAMER PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
EXXUA (GEPIRONE HYDROCHLORIDE)
EQ 54.5MG BASE
Marketing Status: Prescription
Active Ingredient: GEPIRONE HYDROCHLORIDE
Proprietary Name: EXXUA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 54.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021164
Product Number: 003
Approval Date: Sep 22, 2023
Applicant Holder Full Name: FABRE KRAMER PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
EXXUA (GEPIRONE HYDROCHLORIDE)
EQ 72.6MG BASE
Marketing Status: Prescription
Active Ingredient: GEPIRONE HYDROCHLORIDE
Proprietary Name: EXXUA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 72.6MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021164
Product Number: 004
Approval Date: Sep 22, 2023
Applicant Holder Full Name: FABRE KRAMER PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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