Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022396
Company: JAVELIN PHARMS INC
Company: JAVELIN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DYLOJECT | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/23/2014 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022396s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022396Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022396Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/09/2016 | SUPPL-3 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022396s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022396Orig1s003ltr.pdf | |
| 05/27/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/09/2016 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022396s003lbl.pdf | |
| 05/09/2016 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022396s003lbl.pdf | |
| 12/23/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022396s000lbledt.pdf |