Details for New Drug Application (NDA): 022202
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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 Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased 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: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jun 16, 2009 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | May 25, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 24, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 24, 2029 | Product 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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