Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203315
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXEMESTANE EXEMESTANE 25MG 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
03/10/2017 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/22/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

EXEMESTANE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AROMASIN EXEMESTANE 25MG TABLET;ORAL Prescription Yes AB 020753 PHARMACIA AND UPJOHN
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 200898 ALVOGEN
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 206421 AMNEAL PHARMS
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 210323 CIPLA
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 203315 MYLAN
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 209208 UPSHER SMITH LABS
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 077431 WEST-WARD PHARMS INT
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 202602 ZYDUS PHARMS

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