Product Details for ANDA 078026
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Discontinued
EQ 20MG BASE
Marketing Status: Discontinued
EQ 30MG BASE
Marketing Status: Discontinued
EQ 40MG BASE
Marketing Status: Discontinued
EQ 10MG BASE
Marketing Status: Discontinued
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078026
Product Number: 001
Approval Date: Jun 29, 2007
Applicant Holder Full Name: ROXANE LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078026
Product Number: 001
Approval Date: Jun 29, 2007
Applicant Holder Full Name: ROXANE LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 20MG BASE
Marketing Status: Discontinued
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078026
Product Number: 002
Approval Date: Jun 29, 2007
Applicant Holder Full Name: ROXANE LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078026
Product Number: 002
Approval Date: Jun 29, 2007
Applicant Holder Full Name: ROXANE LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 30MG BASE
Marketing Status: Discontinued
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078026
Product Number: 003
Approval Date: Jun 29, 2007
Applicant Holder Full Name: ROXANE LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078026
Product Number: 003
Approval Date: Jun 29, 2007
Applicant Holder Full Name: ROXANE LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 40MG BASE
Marketing Status: Discontinued
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078026
Product Number: 004
Approval Date: Jun 29, 2007
Applicant Holder Full Name: ROXANE LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078026
Product Number: 004
Approval Date: Jun 29, 2007
Applicant Holder Full Name: ROXANE LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information