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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020796
Company: ORION PHARMA

Products on NDA 020796

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COMTAN	ENTACAPONE	200MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020796

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.

Labels for NDA 020796

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

Therapeutic Equivalents for NDA 020796

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	212601	ALEMBIC
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
ENTACAPONE	ENTACAPONE	200MG	TABLET;ORAL	Prescription	No	AB	078941	WOCKHARDT BIO AG

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