Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020541
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARIMIDEX ANASTROZOLE 1MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/27/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/02/2014 SUPPL-29 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020541s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020541Orig1s029ltr.pdf
05/01/2013 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020541s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020541Orig1s027ltr.pdf
04/18/2011 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020541s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020541s026ltr.pdf
04/30/2009 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf
04/30/2009 SUPPL-24 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf
12/10/2008 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020, s023ltr.pdf
12/10/2008 SUPPL-21 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf
12/10/2008 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020, s023ltr.pdf
05/10/2006 SUPPL-18 Labeling-Container/Carton Labels

Label is not available on this site.

09/16/2005 SUPPL-16 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020541s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020541s016ltr.pdf
08/30/2004 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020541s015.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20541s015ltr.pdf
09/05/2002 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20541s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20541se1-010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-541s010_Arimidex.cfm
09/10/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/02/2001 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/01/2000 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20541S06LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex.cfm
10/07/2002 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20541slr005,009ltr.pdf
08/13/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/19/1997 SUPPL-3 Labeling

Label is not available on this site.

02/06/1998 SUPPL-2 Labeling

Label is not available on this site.

10/18/1996 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/02/2014 SUPPL-29 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020541s029lbl.pdf
05/01/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020541s027lbl.pdf
04/18/2011 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020541s026lbl.pdf
04/30/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf
04/30/2009 SUPPL-24 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf
12/10/2008 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf
12/10/2008 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf
12/10/2008 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf
09/16/2005 SUPPL-16 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020541s016lbl.pdf
08/30/2004 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020541s015.pdf
09/05/2002 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20541s10lbl.pdf
09/01/2000 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex_prntlbl.pdf

ARIMIDEX

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 091177 SUN PHARM INDS LTD
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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