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Details for New Drug Application (NDA): 022202

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NDA 022202 describes ZIPSOR, which is a drug marketed by Depomed Inc and is included in one NDA. It is available from three suppliers. There are seven 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. Twenty-three suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

Summary for NDA: 022202

Tradename:
ZIPSOR
Applicant:
Depomed Inc
Ingredient:
diclofenac potassium
Patents:7
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022202

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 Depomed, Inc. 13913-008 13913-008-11 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-11)
ZIPSOR
diclofenac potassium
CAPSULE;ORAL 022202 NDA Depomed, Inc. 13913-008 13913-008-12 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jun 16, 2009TE:ABRLD:Yes
Patent:6,287,594Patent Expiration:Jan 15, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:8,623,920Patent Expiration:Feb 24, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
Patent:6,365,180Patent Expiration:Jul 15, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN


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