Details for New Drug Application (NDA): 207233
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NDA 207233 describes VIVLODEX, which is a drug marketed by Iceutica Operations and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VIVLODEX profile page.
The generic ingredient in VIVLODEX is meloxicam. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
The generic ingredient in VIVLODEX is meloxicam. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
Summary for 207233
| Tradename: | VIVLODEX |
| Applicant: | Iceutica Operations |
| Ingredient: | meloxicam |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 22, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 31, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 31, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 31, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 10 MG OF MELOXICAM | ||||||||
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