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Last Updated: December 12, 2019

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Details for New Drug Application (NDA): 021427

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NDA 021427 describes CYMBALTA, which is a drug marketed by Lilly and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the CYMBALTA profile page.

The generic ingredient in CYMBALTA is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 021427
Tradename:CYMBALTA
Applicant:Lilly
Ingredient:duloxetine hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021427
Suppliers and Packaging for NDA: 021427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 NDA Eli Lilly and Company 0002-3235 0002-3235-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3235-60)
CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 NDA Eli Lilly and Company 0002-3240 0002-3240-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3240-30)
Paragraph IV (Patent) Challenges for 021427
Tradename Dosage Ingredient NDA Submissiondate
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 2012-05-10
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 2008-08-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Aug 3, 2004TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 10, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Aug 3, 2004TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 10, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Aug 3, 2004TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 10, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021427

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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