Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205060
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPANOVA | OMEGA-3-CARBOXYLIC ACIDS | 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/05/2014 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205060s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205060Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205060Orig1EpanovaTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/09/2017 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/30/2016 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205060Orig1s004ltr.pdf |
| 03/09/2017 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205060s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205060Orig1s003ltr.pdf | |
| 10/07/2016 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205060s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205060Orig1s002ltr.pdf | |
| 05/27/2016 | 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 |
|---|---|---|---|---|---|
| 03/09/2017 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205060s003lbl.pdf | |
| 10/07/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205060s002lbl.pdf | |
| 05/05/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205060s000lbl.pdf |