Product Details for ANDA 090723
DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Discontinued
EQ 30MG BASE
Marketing Status: Discontinued
EQ 60MG BASE
Marketing Status: Discontinued
EQ 20MG BASE
Marketing Status: Discontinued
Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: DULOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A090723
Product Number: 001
Approval Date: Dec 11, 2013
Applicant Holder Full Name: MARKSANS PHARMA LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)
Proprietary Name: DULOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A090723
Product Number: 001
Approval Date: Dec 11, 2013
Applicant Holder Full Name: MARKSANS PHARMA LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 30MG BASE
Marketing Status: Discontinued
Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: DULOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A090723
Product Number: 002
Approval Date: Dec 11, 2013
Applicant Holder Full Name: MARKSANS PHARMA LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)
Proprietary Name: DULOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A090723
Product Number: 002
Approval Date: Dec 11, 2013
Applicant Holder Full Name: MARKSANS PHARMA LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 60MG BASE
Marketing Status: Discontinued
Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: DULOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A090723
Product Number: 003
Approval Date: Dec 11, 2013
Applicant Holder Full Name: MARKSANS PHARMA LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DULOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A090723
Product Number: 003
Approval Date: Dec 11, 2013
Applicant Holder Full Name: MARKSANS PHARMA LTD
Marketing Status: Discontinued
Patent and Exclusivity Information