Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207934
Company: PAR PHARM
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 None (Tentative Approval) None 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
12/09/2019 ORIG-2 Tentative Approval STANDARD

Label is not available on this site.

12/09/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207934Orig1s000ltr.pdf

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 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 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 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

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