Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205775
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVEROLIMUS EVEROLIMUS 0.25MG TABLET;ORAL Prescription AB No No
EVEROLIMUS EVEROLIMUS 0.5MG TABLET;ORAL Prescription AB No No
EVEROLIMUS EVEROLIMUS 0.75MG TABLET;ORAL Prescription AB No No
EVEROLIMUS EVEROLIMUS 1MG 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
10/18/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205775Orig1s000ltr.pdf

EVEROLIMUS

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EVEROLIMUS EVEROLIMUS 0.25MG TABLET;ORAL Prescription No AB 214138 ALKEM LABS LTD
EVEROLIMUS EVEROLIMUS 0.25MG TABLET;ORAL Prescription No AB 205432 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 0.25MG TABLET;ORAL Prescription No AB 206133 HIKMA
EVEROLIMUS EVEROLIMUS 0.25MG TABLET;ORAL Prescription No AB 205775 PAR PHARM
ZORTRESS EVEROLIMUS 0.25MG TABLET;ORAL Prescription Yes AB 021560 NOVARTIS

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EVEROLIMUS EVEROLIMUS 0.5MG TABLET;ORAL Prescription No AB 214138 ALKEM LABS LTD
EVEROLIMUS EVEROLIMUS 0.5MG TABLET;ORAL Prescription No AB 205432 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 0.5MG TABLET;ORAL Prescription No AB 206133 HIKMA
EVEROLIMUS EVEROLIMUS 0.5MG TABLET;ORAL Prescription No AB 205775 PAR PHARM
ZORTRESS EVEROLIMUS 0.5MG TABLET;ORAL Prescription Yes AB 021560 NOVARTIS

TABLET;ORAL; 0.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EVEROLIMUS EVEROLIMUS 0.75MG TABLET;ORAL Prescription No AB 214138 ALKEM LABS LTD
EVEROLIMUS EVEROLIMUS 0.75MG TABLET;ORAL Prescription No AB 205432 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 0.75MG TABLET;ORAL Prescription No AB 206133 HIKMA
EVEROLIMUS EVEROLIMUS 0.75MG TABLET;ORAL Prescription No AB 205775 PAR PHARM
ZORTRESS EVEROLIMUS 0.75MG TABLET;ORAL Prescription Yes AB 021560 NOVARTIS

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EVEROLIMUS EVEROLIMUS 1MG TABLET;ORAL Prescription No AB 214138 ALKEM LABS LTD
EVEROLIMUS EVEROLIMUS 1MG TABLET;ORAL Prescription No AB 206133 HIKMA
EVEROLIMUS EVEROLIMUS 1MG TABLET;ORAL Prescription No AB 205775 PAR PHARM
ZORTRESS EVEROLIMUS 1MG TABLET;ORAL Prescription Yes AB 021560 NOVARTIS

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