Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021654
Company: WOODWARD
Company: WOODWARD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOVAZA | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/10/2004 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21654lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21654ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-654_Omacor.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/04/2020 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021654s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021654Orig1s044ltr.pdf | |
| 04/03/2019 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021654s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021654Orig1s043ltr.pdf | |
| 03/09/2015 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/2014 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021654s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021654s041ltr.pdf | |
| 06/05/2014 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/2013 | SUPPL-39 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s039lbl.pdf | |
| 11/15/2013 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/2013 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021654Orig1s037ltr.pdf | |
| 08/31/2012 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021654s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021654Orig1s034ltr.pdf | |
| 09/19/2011 | SUPPL-33 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021654s033ltr.pdf |
| 08/11/2011 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 12/22/2010 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021654s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021654s030ltr.pdf | |
| 04/20/2009 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021654s023ltr.pdf | |
| 09/16/2009 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021654s022ltr.pdf | |
| 06/03/2008 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021654s021lblR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021654s021ltr.pdf | |
| 01/24/2008 | SUPPL-18 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021654Orig1s018.pdf |
| 06/12/2007 | SUPPL-16 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021853s000, 021654s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853_021654s016_omacor_toc.cfm |
| 12/06/2007 | SUPPL-15 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s015ltr.pdf |
| 11/07/2007 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s014ltr.pdf |
| 07/03/2006 | SUPPL-7 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021654s007LTR.pdf |
| 02/01/2007 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021654s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/04/2020 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021654s044lbl.pdf | |
| 04/03/2019 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021654s043lbl.pdf | |
| 05/14/2014 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021654s041lbl.pdf | |
| 09/11/2013 | SUPPL-39 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s039lbl.pdf |
| 06/26/2013 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s037lbl.pdf | |
| 08/31/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021654s034lbl.pdf | |
| 12/22/2010 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021654s030lbl.pdf | |
| 09/16/2009 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s022lbl.pdf | |
| 04/20/2009 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s023lbl.pdf | |
| 06/03/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021654s021lblR.pdf | |
| 02/01/2007 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021654s004lbl.pdf | |
| 11/10/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21654lbl.pdf |
LOVAZA
CAPSULE;ORAL; 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LOVAZA | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | Yes | AB | 021654 | WOODWARD |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 204940 | AMNEAL PHARMS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 090973 | APOTEX |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 207420 | ASCENT PHARMS INC |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 206455 | CHARTWELL |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 211979 | CSPC-NBP PHARM |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 091028 | GLW |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 212504 | GLW |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 215458 | MANKIND PHARMA |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 210093 | PURACAP PHARM LLC |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 211345 | SLAYBACK PHARMA LLC |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 211355 | SOFGEN PHARMS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 203893 | STRIDES PHARMA |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 210834 | SUN PHARM |