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Details for New Drug Application (NDA): 204592

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NDA 204592 describes ZORVOLEX, which is a drug marketed by Iroko Pharms Llc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZORVOLEX profile page.

The generic ingredient in ZORVOLEX is diclofenac. There are forty-seven drug master file entries for this compound. One supplier is listed for this compound. There are five tentative approvals for this compound. Additional details are available on the diclofenac profile page.

Summary for NDA: 204592

Tradename:
ZORVOLEX
Applicant:
Iroko Pharms Llc
Ingredient:
diclofenac
Patents:7
Formulation / Manufacturing:see details

Pharmacology for NDA: 204592

Suppliers and Packaging for NDA: 204592

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZORVOLEX
diclofenac
CAPSULE;ORAL 204592 NDA Iroko Pharmaceuticals LLC 42211-203 42211-203-23 30 CAPSULE in 1 BOTTLE (42211-203-23)
ZORVOLEX
diclofenac
CAPSULE;ORAL 204592 NDA Iroko Pharmaceuticals LLC 42211-203 42211-203-29 90 CAPSULE in 1 BOTTLE (42211-203-29)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength18MG
Approval Date:Oct 18, 2013TE:RLD:No
Patent:8,679,544Patent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:9,017,721Patent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:9,173,854Patent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?


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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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