Details for New Drug Application (NDA): 022165
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NDA 022165 describes CAMBIA, which is a drug marketed by Cosette and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CAMBIA profile page.
The generic ingredient in CAMBIA is diclofenac potassium. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
The generic ingredient in CAMBIA is diclofenac potassium. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 022165
| Tradename: | CAMBIA |
| Applicant: | Cosette |
| Ingredient: | diclofenac potassium |
| Patents: | 4 |
Pharmacology for NDA: 022165
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 022165
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165 | NDA | Assertio Therapeutics, Inc. | 13913-012 | 13913-012-02 | 9 PACKET in 1 CARTON (13913-012-02) / 1 POWDER, FOR SOLUTION in 1 PACKET |
| CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165 | NDA | Assertio Therapeutics, Inc. | 13913-012 | 13913-012-03 | 9 PACKET in 1 CARTON (13913-012-03) / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 50MG | ||||
| Approval Date: | Jun 17, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,759,394 | Patent Expiration: | Jun 16, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS | ||||||||
| Patent: | 8,097,651 | Patent Expiration: | Jun 16, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS | ||||||||
| Patent: | 8,927,604 | Patent Expiration: | Jun 16, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS | ||||||||
Expired US Patents for NDA 022165
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cosette | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | 9,827,197 | ⤷ Start Trial |
| Cosette | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | 6,974,595 | ⤷ Start Trial |
| Cosette | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | 7,759,394 | ⤷ Start Trial |
| Cosette | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | 7,482,377 | ⤷ Start Trial |
| Cosette | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | 8,097,651 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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