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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077431
Company: HIKMA
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
04/01/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077431s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/15/2022 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

08/13/2020 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/13/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/06/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/06/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/03/2011 SUPPL-1 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 PFIZER
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 200898 ALVOGEN
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 211031 BRECKENRIDGE
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 210323 CIPLA
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 216454 EUGIA PHARMA
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 077431 HIKMA
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 213547 QILU
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 203315 RISING
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 209208 UPSHER SMITH LABS
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 202602 ZYDUS PHARMS
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