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): 210226
Company: LUPIN

Products on ANDA 210226

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210226

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2020	ORIG-1	Approval		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
02/16/2024	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/16/2024	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/16/2024	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/16/2024	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210226

DIMETHYL FUMARATE

CAPSULE, DELAYED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210499	ACCORD HLTHCARE
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210440	ALKEM LABS LTD
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210402	AMNEAL
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210385	AUROBINDO PHARMA
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210305	CIPLA
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210309	GLENMARK PHARMS LTD
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210500	HETERO LABS LTD III
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210226	LUPIN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210460	MSN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210531	MYLAN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210414	PRINSTON INC
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210436	SOLA PHARMS
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210382	TWI PHARMS
TECFIDERA	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	204063	BIOGEN INC

CAPSULE, DELAYED RELEASE;ORAL; 240MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210499	ACCORD HLTHCARE
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210440	ALKEM LABS LTD
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210402	AMNEAL
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210385	AUROBINDO PHARMA
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210305	CIPLA
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210309	GLENMARK PHARMS LTD
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210500	HETERO LABS LTD III
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210226	LUPIN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210460	MSN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210531	MYLAN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210414	PRINSTON INC
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210436	SOLA PHARMS
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210382	TWI PHARMS
TECFIDERA	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	204063	BIOGEN INC

Top