Product Details for ANDA 213485
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
EQ 12.5MG BASE
Marketing Status: Prescription
EQ 25MG BASE
Marketing Status: Prescription
EQ 37.5MG BASE
Marketing Status: Prescription
EQ 12.5MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213485
Product Number: 001
Approval Date: Feb 16, 2021
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213485
Product Number: 001
Approval Date: Feb 16, 2021
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213485
Product Number: 002
Approval Date: Feb 16, 2021
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213485
Product Number: 002
Approval Date: Feb 16, 2021
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 37.5MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213485
Product Number: 003
Approval Date: Feb 16, 2021
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213485
Product Number: 003
Approval Date: Feb 16, 2021
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information