Product Details for ANDA 204815
DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription
EQ 30MG BASE
Marketing Status: Prescription
EQ 60MG BASE
Marketing Status: Prescription
EQ 20MG BASE
Marketing Status: Prescription
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: AB
Application Number: A204815
Product Number: 001
Approval Date: Mar 23, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
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: AB
Application Number: A204815
Product Number: 001
Approval Date: Mar 23, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 30MG BASE
Marketing Status: Prescription
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: AB
Application Number: A204815
Product Number: 002
Approval Date: Mar 23, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
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: AB
Application Number: A204815
Product Number: 002
Approval Date: Mar 23, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 60MG BASE
Marketing Status: Prescription
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: AB
Application Number: A204815
Product Number: 003
Approval Date: Mar 23, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
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: AB
Application Number: A204815
Product Number: 003
Approval Date: Mar 23, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information