Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021549
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMEND | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| EMEND | APREPITANT | 125MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| EMEND | APREPITANT | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/26/2003 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21549_Emend_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21549ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-549_Emend.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/25/2019 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s031,207865s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021549Orig1s031, 207865Orig1s004ltr.pdf | |
| 11/14/2019 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s030,207865s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021549Orig1s030, 022023Orig1s019, 207865Orig1s003ltr.pdf | |
| 05/31/2017 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021549s027,207865s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021549Orig1s027,207865Orig1s001ltr.pdf | |
| 01/12/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/2015 | SUPPL-25 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021549s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021549Orig1s025ltr.pdf | |
| 08/12/2014 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021549s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021549Orig1s024,022023Orig1s011ltr.pdf | |
| 03/27/2013 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s023,022023Orig1s010ltr.pdf | |
| 07/06/2012 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021549s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021549Orig1s021ltr.pdf | |
| 03/20/2013 | SUPPL-19 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s019ltr.pdf | |
| 03/19/2010 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021549s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021549s017ltr.pdf | |
| 02/02/2009 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021549s016ltr.pdf | |
| 11/18/2008 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021549s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021549s015ltr.pdf | |
| 07/21/2009 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021549s014ltr.pdf | |
| 11/15/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021549s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021549s012ltr.pdf | |
| 06/09/2006 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s011rev1.pdf | |
| 06/30/2006 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s010LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021549Orig1s010.pdf | |
| 06/09/2005 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021549s009ltr.pdf | |
| 10/28/2005 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021549s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021549Orig1S008.pdf | |
| 12/22/2004 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549s007ltr.pdf | |
| 12/15/2004 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549s004ltr.pdf | |
| 01/15/2004 | SUPPL-2 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549slr002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021549_S002_EMEND.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/14/2019 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s030,207865s003lbl.pdf | |
| 09/25/2019 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s031,207865s004lbl.pdf | |
| 05/31/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021549s027,207865s001lbl.pdf | |
| 08/28/2015 | SUPPL-25 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021549s025lbl.pdf | |
| 08/12/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021549s024lbl.pdf | |
| 03/27/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s023lbl.pdf | |
| 03/20/2013 | SUPPL-19 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s019lbl.pdf | |
| 03/20/2013 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s019lbl.pdf | |
| 07/06/2012 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021549s021lbl.pdf | |
| 03/19/2010 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021549s017lbl.pdf | |
| 07/21/2009 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s014lbl.pdf | |
| 02/02/2009 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s016lbl.pdf | |
| 11/18/2008 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021549s015lbl.pdf | |
| 11/15/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021549s012lbl.pdf | |
| 06/30/2006 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s010lbl.pdf | |
| 06/09/2006 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s011lbl.pdf | |
| 10/28/2005 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s008lbl.pdf | |
| 06/09/2005 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s009lbl.pdf | |
| 12/22/2004 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s007lbl.pdf | |
| 12/15/2004 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s004lbl.pdf | |
| 03/26/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21549_Emend_lbl.pdf |
EMEND
CAPSULE;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APREPITANT | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | No | AB | 207777 | GLENMARK PHARMS SA |
| APREPITANT | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | No | AB | 090999 | SANDOZ |
| APREPITANT | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | No | AB | 211835 | TORRENT |
| EMEND | APREPITANT | 80MG | CAPSULE;ORAL | Prescription | Yes | AB | 021549 | MERCK |
CAPSULE;ORAL; 125MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APREPITANT | APREPITANT | 125MG | CAPSULE;ORAL | Prescription | No | AB | 207777 | GLENMARK PHARMS SA |
| APREPITANT | APREPITANT | 125MG | CAPSULE;ORAL | Prescription | No | AB | 090999 | SANDOZ |
| APREPITANT | APREPITANT | 125MG | CAPSULE;ORAL | Prescription | No | AB | 211835 | TORRENT |
| EMEND | APREPITANT | 125MG | CAPSULE;ORAL | Prescription | Yes | AB | 021549 | MERCK |