Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211310

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DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)
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: A211310
Product Number: 001
Approval Date: Oct 16, 2018
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)
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: A211310
Product Number: 002
Approval Date: Oct 16, 2018
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)
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: A211310
Product Number: 003
Approval Date: Oct 16, 2018
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information