Product Details for NDA 020936
PAXIL CR (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: PAXIL CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020936
Product Number: 001
Approval Date: Feb 16, 1999
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
PAXIL CR (PAROXETINE HYDROCHLORIDE)
Proprietary Name: PAXIL CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020936
Product Number: 001
Approval Date: Feb 16, 1999
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020936
Product Number: 002
Approval Date: Feb 16, 1999
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
PAXIL CR (PAROXETINE HYDROCHLORIDE)
Proprietary Name: PAXIL CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020936
Product Number: 002
Approval Date: Feb 16, 1999
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 37.5MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020936
Product Number: 003
Approval Date: Dec 6, 2000
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PAXIL CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020936
Product Number: 003
Approval Date: Dec 6, 2000
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information