Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050797
Company: PF PRISM CV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZMAX AZITHROMYCIN EQ 2GM BASE/BOT FOR SUSPENSION, EXTENDED RELEASE;ORAL Discontinued None Yes 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
06/10/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050797lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050797ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050797s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/30/2017 SUPPL-24 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/2017/050797s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050797Orig1s024ltr.pdf
06/27/2016 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/09/2017 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050797s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050797Orig1s021ltr.pdf
05/24/2016 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050797s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050797Orig1s020ltr.pdf
07/02/2015 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050797s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050797Orig1s019ltr.pdf
02/19/2013 SUPPL-17 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050797Orig1s017ltr.pdf
03/01/2012 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050797s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050797s016ltr.pdf
06/07/2011 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf
10/11/2013 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050797Orig1s013ltr.pdf
06/07/2011 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf
06/07/2011 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf
10/07/2008 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050797s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050797s008ltr.pdf
10/25/2007 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050797s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050797s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/30/2017 SUPPL-24 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/2017/050797s024lbl.pdf
02/09/2017 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050797s021lbl.pdf
05/24/2016 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050797s020lbl.pdf
07/02/2015 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050797s019lbl.pdf
10/11/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s013lbl.pdf
02/19/2013 SUPPL-17 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf
02/19/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf
03/01/2012 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050797s016lbl.pdf
06/07/2011 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf
06/07/2011 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf
06/07/2011 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf
10/07/2008 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050797s008lbl.pdf
10/25/2007 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050797s001lbl.pdf
06/10/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050797lbl.pdf

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