Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050733
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZITHROMAX AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
01/30/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050733Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050733ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/24/2019 SUPPL-47 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050733s047lbl.pdf
03/29/2017 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050733s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050733Orig1s046ltr.pdf
02/10/2017 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050733s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050733Orig1s043ltr.pdf
05/24/2016 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050733s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050733Orig1s040ltr.pdf
06/24/2014 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

02/19/2013 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050733s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050733Orig1s035ltr.pdf
06/06/2012 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf
11/16/2011 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050733s033ltr.pdf
06/06/2014 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050733s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050733Orig1s031ltr.pdf
01/28/2011 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s030.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf
08/11/2010 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050733s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050733s029ltr.pdf
03/06/2009 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050733s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050733s023ltr.pdf
10/25/2007 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050733s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050733s018ltr.pdf
01/15/2004 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50733slr013ltr.pdf
01/15/2004 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50733slr012ltr.pdf
07/22/2002 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf
03/13/2002 SUPPL-9 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733s9ltr.pdf
12/10/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/12/2003 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50733slr007ltr.pdf
10/16/2002 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733slr006ltr.pdf
02/28/2001 SUPPL-5 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50733s5lbl.pdf
11/11/2000 SUPPL-4 Labeling

Label is not available on this site.

11/22/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/19/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/20/1999 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
04/24/2019 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050733s047lbl.pdf
03/29/2017 SUPPL-46 Labeling Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050733s046lbl.pdf
02/10/2017 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050733s043lbl.pdf
05/24/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050733s040lbl.pdf
06/06/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050733s031lbl.pdf
02/19/2013 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050733s035lbl.pdf
06/06/2012 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf
11/16/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s033lbl.pdf
01/28/2011 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s030.pdf
08/11/2010 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050733s029lbl.pdf
03/06/2009 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050733s023lbl.pdf
10/25/2007 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050733s018lbl.pdf
02/28/2001 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50733s5lbl.pdf

ZITHROMAX

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203294 AUROBINDO PHARMA LTD
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065179 FRESENIUS KABI USA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065501 GLAND PHARMA LTD
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203412 HAINAN POLY PHARM
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065500 HOSPIRA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065511 HOSPIRA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065506 MYLAN ASI
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204732 MYLAN LABS LTD
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090923 SUN PHARM INDS LTD
ZITHROMAX AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050733 PFIZER

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