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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210414
Company: PRINSTON INC

Products on ANDA 210414

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 210414

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/2022	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
11/04/2024	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/04/2024	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
11/04/2024	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/04/2024	SUPPL-1	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 210414

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	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	210377	MACLEODS PHARMS LTD
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	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	210377	MACLEODS PHARMS LTD
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

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