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

Abbreviated New Drug Application (ANDA): 078963
Company: ORBION PHARMS

Products on ANDA 078963

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	AB	No	No
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078963

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/28/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078963

MODAFINIL

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	202700	ALEMBIC
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	077667	APOTEX
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	207196	APPCO
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	202566	AUROBINDO PHARMA LTD
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	209966	CADILA
MODAFINIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	No	AB	078963	ORBION PHARMS
PROVIGIL	MODAFINIL	100MG	TABLET;ORAL	Prescription	Yes	AB	020717	NUVO PHARMS

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	202700	ALEMBIC
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	077667	APOTEX
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	207196	APPCO
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	202566	AUROBINDO PHARMA LTD
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	209966	CADILA
MODAFINIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	No	AB	078963	ORBION PHARMS
PROVIGIL	MODAFINIL	200MG	TABLET;ORAL	Prescription	Yes	AB	020717	NUVO PHARMS

Top