Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210531
Company: MYLAN
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/17/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210531Orig1s000ltr.pdf

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 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 ATLANTIS
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 210436 PHARMATHEN
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 IDEC 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 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 ATLANTIS
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 210436 PHARMATHEN
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 IDEC INC

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