Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021549
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 CAPSULE;ORAL Prescription AB 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
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-Package Insert, Labeling-Patient 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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s010LTR.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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s019lbl.pdf
03/20/2013 SUPPL-19 Labeling-Patient 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
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
EMEND APREPITANT 125MG CAPSULE;ORAL Prescription Yes AB 021549 MERCK

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APREPITANT APREPITANT 40MG CAPSULE;ORAL Prescription No AB 207777 GLENMARK PHARMS SA
APREPITANT APREPITANT 40MG CAPSULE;ORAL Prescription No AB 090999 SANDOZ
EMEND APREPITANT 40MG CAPSULE;ORAL Prescription Yes AB 021549 MERCK

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