Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020718
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTEGRILIN EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
INTEGRILIN EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION 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
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
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
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

INTEGRILIN

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 205557 ACCORD HLTHCARE
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 204589 AKORN
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 205581 AMNEAL PHARMS
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 206127 AUROBINDO PHARMA LTD
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 208554 BAXTER HLTHCARE CORP
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 209864 HAINAN POLY PHARM
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 203258 MYLAN LABS LTD
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 204693 SAGENT PHARMS INC
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 090854 TEVA PHARMS USA
INTEGRILIN EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription Yes AP 020718 SCHERING

INJECTABLE;INJECTION; 75MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 205557 ACCORD HLTHCARE
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 204589 AKORN
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 205581 AMNEAL PHARMS
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 206127 AUROBINDO PHARMA LTD
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 208554 BAXTER HLTHCARE CORP
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 209864 HAINAN POLY PHARM
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 203258 MYLAN LABS LTD
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 204693 SAGENT PHARMS INC
INTEGRILIN EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription Yes AP 020718 SCHERING

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