Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020718
Company: MSD SUB MERCK
Company: MSD SUB MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INTEGRILIN | EPTIFIBATIDE | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| INTEGRILIN | EPTIFIBATIDE | 75MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/18/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20718lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20718ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20718_Integrilin.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2021 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020718s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020718Orig1s039ltr.pdf | |
| 03/25/2013 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020718s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020718Orig1s037ltr.pdf | |
| 03/30/2011 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020718s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020718s034ltr.pdf | |
| 12/15/2008 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020718s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020718s028ltr.pdf | |
| 10/12/2005 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020718s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020718s025ltr.pdf | |
| 07/15/2004 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20718s022ltr.pdf |
| 06/16/2003 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20718se8-017_integrilin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20718se8-017ltr.pdf | |
| 02/14/2002 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/2001 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/2001 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20718S10S13ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-718_Integrilin.cfm | |
| 07/03/2001 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/2001 | SUPPL-10 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20718S10S13ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-718_Integrilin.cfm | |
| 05/31/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/20/1999 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20718s02lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20718s02ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20718S002_Integrilin.cfm | |
| 09/11/1998 | 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 |
|---|---|---|---|---|---|
| 02/28/2021 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020718s039lbl.pdf | |
| 03/25/2013 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020718s037lbl.pdf | |
| 03/30/2011 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020718s034lbl.pdf | |
| 12/15/2008 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020718s028lbl.pdf | |
| 10/12/2005 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020718s025lbl.pdf | |
| 06/16/2003 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20718se8-017_integrilin_lbl.pdf | |
| 06/08/2001 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf | |
| 06/08/2001 | SUPPL-10 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf | |
| 09/20/1999 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20718s02lbl.pdf | |
| 05/18/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20718lbl.pdf |