Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212936
Company: MYLAN
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
06/08/2020 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 PHARMS
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 PHARMS
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 PHARMS
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 212936 MYLAN
EVEROLIMUS EVEROLIMUS 10MG TABLET;ORAL Prescription No AB 207934 PAR PHARM

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English