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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208327
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription AB No No
ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG 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
01/07/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208327Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/20/2020 SUPPL-10 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

11/04/2019 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

ABIRATERONE ACETATE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208327 AMNEAL PHARMS
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208453 APOTEX
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208416 DR REDDYS
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 209227 GLENMARK PHARMS
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208339 HIKMA
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 210686 MSN
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208446 MYLAN
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 215947 ONCOGEN PHARMA
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 212462 QILU
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208371 RISING
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208432 TEVA PHARMS USA
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208380 WOCKHARDT BIO AG
ZYTIGA ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription Yes AB 202379 JANSSEN BIOTECH

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET;ORAL Prescription No AB 208327 AMNEAL PHARMS
ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET;ORAL Prescription No AB 209227 GLENMARK PHARMS
ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET;ORAL Prescription No AB 208446 MYLAN
ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET;ORAL Prescription No AB 215947 ONCOGEN PHARMA
ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET;ORAL Prescription No AB 212462 QILU
ZYTIGA ABIRATERONE ACETATE 500MG TABLET;ORAL Prescription Yes AB 202379 JANSSEN BIOTECH
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