An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021875
Company: NUVO PHARMS

Medication Guide

Products on NDA 021875

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUVIGIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	AB	Yes	No
NUVIGIL	ARMODAFINIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
NUVIGIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	AB	Yes	No
NUVIGIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	AB	Yes	Yes
NUVIGIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021875

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2007	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021875s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021875_nuvigil_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2017	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021875Orig1s023ltr.pdf
04/16/2015	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021875Orig1s021ltr.pdf
02/09/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
08/23/2013	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/05/2013	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
01/13/2012	SUPPL-17	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf
01/13/2012	SUPPL-16	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf
10/21/2010	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf
06/28/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021875Orig1s012ltr.pdf
10/21/2010	SUPPL-8	Labeling, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf
03/26/2009	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021875s006ltr.pdf
10/21/2010	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf

Labels for NDA 021875

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf
04/16/2015	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf
06/28/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf
10/21/2010	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
10/21/2010	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
10/21/2010	SUPPL-8	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
10/21/2010	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
06/15/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf

Therapeutic Equivalents for NDA 021875

NUVIGIL

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	206069	AUROBINDO PHARMA LTD
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	201514	COREPHARMA
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	200043	MYLAN PHARMS INC
ARMODAFINIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	No	AB	202768	NATCO PHARMA LTD
NUVIGIL	ARMODAFINIL	50MG	TABLET;ORAL	Prescription	Yes	AB	021875	NUVO PHARMS

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	206069	AUROBINDO PHARMA LTD
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	201514	COREPHARMA
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	200043	MYLAN PHARMS INC
ARMODAFINIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	No	AB	202768	NATCO PHARMA LTD
NUVIGIL	ARMODAFINIL	150MG	TABLET;ORAL	Prescription	Yes	AB	021875	NUVO PHARMS

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	206069	AUROBINDO PHARMA LTD
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	201514	COREPHARMA
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	200043	MYLAN PHARMS INC
ARMODAFINIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	No	AB	202768	NATCO PHARMA LTD
NUVIGIL	ARMODAFINIL	250MG	TABLET;ORAL	Prescription	Yes	AB	021875	NUVO PHARMS

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARMODAFINIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	206069	AUROBINDO PHARMA LTD
ARMODAFINIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	200751	LUPIN
ARMODAFINIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	200043	MYLAN PHARMS INC
ARMODAFINIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	202768	NATCO PHARMA LTD
NUVIGIL	ARMODAFINIL	200MG	TABLET;ORAL	Prescription	Yes	AB	021875	NUVO PHARMS

Top