Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022023
Company: MERCK AND CO INC
Company: MERCK AND CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMEND | FOSAPREPITANT DIMEGLUMINE | EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAVENOUS | Discontinued | None | Yes | No |
| EMEND | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 01/25/2008 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022023s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/022023s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/02/2022 | SUPPL-21 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022023s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022023Orig1s021ltr.pdf | |
| 11/14/2019 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022023s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021549Orig1s030, 022023Orig1s019, 207865Orig1s003ltr.pdf | |
| 03/26/2018 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022023Orig1s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/022023Orig1s018.pdf | |
| 04/03/2018 | SUPPL-17 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022023s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/022023Orig1s017.pdf | |
| 08/09/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022023Orig1s016ltr.pdf | |
| 05/31/2017 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022023Orig1s015ltr.pdf | |
| 12/02/2016 | SUPPL-14 | Manufacturing (CMC)-Manufacturing Process |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022023Orig1s014.pdf | |
| 01/12/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/2014 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022023s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021549Orig1s024,022023Orig1s011ltr.pdf | |
| 03/27/2013 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s023,022023Orig1s010ltr.pdf | |
| 07/06/2012 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022023s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022023Orig1s009ltr.pdf | |
| 03/20/2013 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022023Orig1s007ltr.pdf | |
| 02/01/2016 | SUPPL-6 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s006lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022023Orig1s006ltr.pdf | |
| 03/23/2010 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf | |
| 11/12/2010 | SUPPL-4 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022023Orig1s004.pdf | |
| 03/23/2010 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf | |
| 03/23/2010 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf | |
| 02/02/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/02/2022 | SUPPL-21 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022023s021lbl.pdf | |
| 11/14/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022023s019lbl.pdf | |
| 04/03/2018 | SUPPL-17 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s017lbl.pdf | |
| 03/26/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s018lbl.pdf | |
| 08/09/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s016lbl.pdf | |
| 05/31/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s015lbl.pdf | |
| 12/02/2016 | SUPPL-14 | Manufacturing (CMC)-Manufacturing Process | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s014lbl.pdf | |
| 02/01/2016 | SUPPL-6 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s006lbledt.pdf | |
| 08/12/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022023s011lbl.pdf | |
| 03/27/2013 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s010lbl.pdf | |
| 03/20/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf | |
| 03/20/2013 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf | |
| 03/20/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf | |
| 07/06/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022023s009lbl.pdf | |
| 11/12/2010 | SUPPL-4 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s004lbl.pdf | |
| 03/23/2010 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf | |
| 03/23/2010 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf | |
| 03/23/2010 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf | |
| 01/25/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022023lbl.pdf |
EMEND
POWDER;INTRAVENOUS; EQ 150MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EMEND | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 022023 | MERCK AND CO INC |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 204025 | ACCORD HLTHCARE |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 214616 | ASPIRO |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211860 | BAXTER HLTHCARE CORP |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 212309 | BE PHARMS |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 212143 | CHIA TAI TIANQING |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211160 | DR REDDYS |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 210625 | EUGIA PHARMA |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206197 | FRESENIUS KABI USA |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 210689 | LUPIN LTD |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 209965 | MSN |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 204015 | MYLAN LABS LTD |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 212957 | NAVINTA LLC |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 214683 | PIRAMAL CRITICAL |
| FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 213106 | QILU PHARM HAINAN |