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 NDA 212516

Expand all

DRIZALMA SPRINKLE (DULOXETINE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: DRIZALMA SPRINKLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212516
Product Number: 001
Approval Date: Jul 19, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DRIZALMA SPRINKLE (DULOXETINE HYDROCHLORIDE)
EQ 30MG BASE
Marketing Status: Prescription
Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: DRIZALMA SPRINKLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212516
Product Number: 002
Approval Date: Jul 19, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DRIZALMA SPRINKLE (DULOXETINE HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: DRIZALMA SPRINKLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212516
Product Number: 003
Approval Date: Jul 19, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DRIZALMA SPRINKLE (DULOXETINE HYDROCHLORIDE)
EQ 60MG BASE
Marketing Status: Prescription
Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: DRIZALMA SPRINKLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212516
Product Number: 004
Approval Date: Jul 19, 2019
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top