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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011961
Company: VALIDUS PHARMS INC

Medication Guide

Other Important Information from FDA

Products on NDA 011961

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MARPLAN	ISOCARBOXAZID	10MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011961

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/1959	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2018	SUPPL-45	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011961s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011961Orig1s045ltr.pdf
11/02/2016	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
08/10/2007	SUPPL-39	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011961s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011961s039ltr.pdf
02/12/2007	SUPPL-38	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
01/12/2005	SUPPL-35	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/11961s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/11961s035ltr.pdf
10/25/2001	SUPPL-34	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/23/2000	SUPPL-33	Labeling		Label is not available on this site.
06/16/1993	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
08/19/1998	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
08/18/1998	SUPPL-17	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/11961lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/11961ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/11961-s017.cfm

Labels for NDA 011961

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2018	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011961s045lbl.pdf
08/10/2007	SUPPL-39	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011961s039lbl.pdf
01/12/2005	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/11961s035lbl.pdf
08/18/1998	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/11961lbl.pdf

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