Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090088
Company: FRESENIUS KABI ONCOL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANASTROZOLE ANASTROZOLE 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
06/28/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090088s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/22/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/16/2011 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

ANASTROZOLE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 090568 ACCORD HLTHCARE
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 200654 APOTEX INC
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 091164 CIPLA LTD
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 090732 DR REDDYS LABS LTD
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 090088 FRESENIUS KABI ONCOL
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 091051 MYLAN
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 079220 NATCO PHARMA LTD
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 078944 SANTOS BIOTECH
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 078058 TEVA PHARMS
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 078485 WEST-WARD PHARMS INT
ANASTROZOLE ANASTROZOLE 1MG TABLET;ORAL Prescription No AB 078921 ZYDUS PHARMS USA INC
ARIMIDEX ANASTROZOLE 1MG TABLET;ORAL Prescription Yes AB 020541 ASTRAZENECA PHARMS

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