U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 090694

Expand all

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: A090694
Product Number: 001
Approval Date: Dec 11, 2013
Applicant Holder Full Name: LUPIN 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: A090694
Product Number: 002
Approval Date: Dec 11, 2013
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: DULOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090694
Product Number: 003
Approval Date: Dec 11, 2013
Applicant Holder Full Name: LUPIN 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: A090694
Product Number: 004
Approval Date: Dec 11, 2013
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top