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 one supplier. 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-nine 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:	0

Pharmacology for NDA: 021427

Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 021427

Analgesics
Antidepressive Agents
Dopamine Agents
Serotonin and Noradrenaline Reuptake Inhibitors

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 20MG BASE
Approval Date:	Aug 3, 2004	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 30MG BASE
Approval Date:	Aug 3, 2004	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 60MG BASE
Approval Date:	Aug 3, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021427

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