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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212516


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NDA 212516 describes DRIZALMA SPRINKLE, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the DRIZALMA SPRINKLE profile page.

The generic ingredient in DRIZALMA SPRINKLE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 212516
Tradename:DRIZALMA SPRINKLE
Applicant:Sun Pharm
Ingredient:duloxetine hydrochloride
Patents:4
Pharmacology for NDA: 212516
Suppliers and Packaging for NDA: 212516
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 NDA SUN PHARMACEUTICAL INDUSTRIES, INC. 47335-616 47335-616-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-10)
DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 NDA SUN PHARMACEUTICAL INDUSTRIES, INC. 47335-616 47335-616-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Jul 19, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 13, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Apr 13, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Apr 13, 2037Product Flag?YSubstance Flag?Delist Request?

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