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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 022202


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NDA 022202 describes ZIPSOR, which is a drug marketed by Assertio and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZIPSOR profile page.

The generic ingredient in ZIPSOR is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 022202
Tradename:ZIPSOR
Applicant:Assertio
Ingredient:diclofenac potassium
Patents:6
Pharmacology for NDA: 022202
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 022202
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIPSOR diclofenac potassium CAPSULE;ORAL 022202 NDA Assertio Therapeutics, Inc. 13913-008 13913-008-11 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-11)
ZIPSOR diclofenac potassium CAPSULE;ORAL 022202 NDA Assertio Therapeutics, Inc. 13913-008 13913-008-12 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jun 16, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 25, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Sign UpPatent Expiration:Feb 24, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
Patent:⤷  Sign UpPatent Expiration:Feb 24, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN

Expired US Patents for NDA 022202

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 ⤷  Sign Up ⤷  Sign Up
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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