Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020031

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PAXIL (PAROXETINE HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020031
Product Number: 001
Approval Date: Dec 29, 1992
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PAXIL (PAROXETINE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020031
Product Number: 002
Approval Date: Dec 29, 1992
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PAXIL (PAROXETINE HYDROCHLORIDE)
EQ 30MG BASE
Marketing Status: Prescription

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020031
Product Number: 003
Approval Date: Dec 29, 1992
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PAXIL (PAROXETINE HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020031
Product Number: 005
Approval Date: Dec 29, 1992
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PAXIL (PAROXETINE HYDROCHLORIDE)
EQ 50MG BASE
Marketing Status: Discontinued

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020031
Product Number: 004
Approval Date: Dec 29, 1992
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Discontinued
Patent and Exclusivity Information