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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 seventeen 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-one drug master file entries for this compound. Fifty-one suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the duloxetine hydrochloride profile page.

Summary for NDA: 021427

Tradename:
CYMBALTA
Applicant:
Lilly
Ingredient:
duloxetine hydrochloride
Patents:1
Therapeutic Class:Antidepressants
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Aug 3, 2004TE:ABRLD:No
Patent:6,596,756*PEDPatent Expiration:Mar 10, 2020Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:Oct 16, 2017
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 18, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired Orange Book Patents for NDA: 021427

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 20045,508,276*PED► subscribe
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 20045,023,269*PED► subscribe
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 20045,023,269*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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