Details for New Drug Application (NDA): 022202
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NDA 022202 describes ZIPSOR, which is a drug marketed by Asio Holdings and is included in one NDA. It is available from three 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-nine suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
The generic ingredient in ZIPSOR is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 022202
| Tradename: | ZIPSOR |
| Applicant: | Asio Holdings |
| 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 | 13913-008-12 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12) |
| ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202 | NDA AUTHORIZED GENERIC | Leading Pharma, LLC | 69315-275 | 69315-275-20 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69315-275-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Jun 16, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | 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 |
|---|---|---|---|---|---|---|---|
| Asio Holdings | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Asio Holdings | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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