Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210130
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVEROLIMUS EVEROLIMUS 2MG TABLET, FOR SUSPENSION;ORAL Prescription AB No No
EVEROLIMUS EVEROLIMUS 3MG TABLET, FOR SUSPENSION;ORAL Prescription AB No No
EVEROLIMUS EVEROLIMUS 5MG TABLET, FOR SUSPENSION;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
04/19/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210130Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/25/2021 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

02/23/2021 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

EVEROLIMUS

TABLET, FOR SUSPENSION;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR DISPERZ EVEROLIMUS 2MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 203985 NOVARTIS PHARM
EVEROLIMUS EVEROLIMUS 2MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210130 MYLAN

TABLET, FOR SUSPENSION;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR DISPERZ EVEROLIMUS 3MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 203985 NOVARTIS PHARM
EVEROLIMUS EVEROLIMUS 3MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210130 MYLAN

TABLET, FOR SUSPENSION;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR DISPERZ EVEROLIMUS 5MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 203985 NOVARTIS PHARM
EVEROLIMUS EVEROLIMUS 5MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210130 MYLAN

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