Details for New Drug Application (NDA): 022396
✉ Email this page to a colleague
NDA 022396 describes DYLOJECT, which is a drug marketed by Javelin Pharms Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DYLOJECT profile page.
The generic ingredient in DYLOJECT is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-five suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
The generic ingredient in DYLOJECT is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-five suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 022396
| Tradename: | DYLOJECT |
| Applicant: | Javelin Pharms Inc |
| Ingredient: | diclofenac sodium |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 23, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 22, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF PAIN | ||||||||
Expired US Patents for NDA 022396
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Javelin Pharms Inc | DYLOJECT | diclofenac sodium | SOLUTION;INTRAVENOUS | 022396-001 | Dec 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
