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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214182
Company: BIOCON PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription AB No No
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription AB No No
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription AB No No
EVEROLIMUS EVEROLIMUS 10MG TABLET;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
02/11/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

EVEROLIMUS

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR EVEROLIMUS 2.5MG TABLET;ORAL Prescription Yes AB 022334 NOVARTIS
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 214182 BIOCON PHARMA
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 205426 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 207486 HIKMA
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 212936 MYLAN
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 207934 PAR PHARM
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 210050 TEVA PHARMS USA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR EVEROLIMUS 5MG TABLET;ORAL Prescription Yes AB 022334 NOVARTIS
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 214182 BIOCON PHARMA
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 205426 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 207486 HIKMA
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 212936 MYLAN
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 207934 PAR PHARM
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 210050 TEVA PHARMS USA

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR EVEROLIMUS 7.5MG TABLET;ORAL Prescription Yes AB 022334 NOVARTIS
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 214182 BIOCON PHARMA
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 205426 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 207486 HIKMA
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 212936 MYLAN
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 207934 PAR PHARM
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 210050 TEVA PHARMS USA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR EVEROLIMUS 10MG TABLET;ORAL Prescription Yes AB 022334 NOVARTIS
EVEROLIMUS EVEROLIMUS 10MG TABLET;ORAL Prescription No AB 214182 BIOCON PHARMA
EVEROLIMUS EVEROLIMUS 10MG TABLET;ORAL Prescription No AB 205426 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 10MG TABLET;ORAL Prescription No AB 207486 HIKMA
EVEROLIMUS EVEROLIMUS 10MG TABLET;ORAL Prescription No AB 212936 MYLAN
EVEROLIMUS EVEROLIMUS 10MG TABLET;ORAL Prescription No AB 207934 PAR PHARM
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