Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020796
Company: ORION PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COMTAN ENTACAPONE 200MG TABLET;ORAL Prescription AB 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
10/19/1999 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20796LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20796LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20796_Comtan.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/22/2016 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020796s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485Orig1s033ltr.pdf
10/16/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/16/2015 SUPPL-24 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020796s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020796Orig1s024ltr.pdf
10/11/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/16/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/13/2014 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020796s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020796Orig1s016ltr.pdf
10/11/2010 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020796s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020ltr.pdf
02/02/2009 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf
02/02/2009 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf
04/18/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/17/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/10/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/14/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/22/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020796s026lbl.pdf
01/16/2015 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020796s024lbl.pdf
06/13/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020796s016lbl.pdf
10/11/2010 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020796s015lbl.pdf
02/02/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf
02/02/2009 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf
10/19/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20796LBL.PDF

COMTAN

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COMTAN ENTACAPONE 200MG TABLET;ORAL Prescription Yes AB 020796 ORION PHARMA
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 205792 AJANTA PHARMA LTD
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 203437 AUROBINDO PHARMA LTD
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 207210 MACLEODS PHARMS LTD
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 090690 SUN PHARM
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 206669 SUNSHINE LAKE
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 078941 WOCKHARDT LTD

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