Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050810
Company: OAK PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZASITE AZITHROMYCIN 1% SOLUTION/DROPS;OPHTHALMIC Prescription None 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
04/27/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050810lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050810s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/050810_azasite_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/12/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/05/2012 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050810s014ltr.pdf
10/16/2012 SUPPL-12 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/050810Orig1s012.pdf
03/31/2011 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050810s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050810s007ltr.pdf
05/06/2009 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf
05/06/2009 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf
05/06/2009 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/16/2012 SUPPL-12 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s012lbl.pdf
07/05/2012 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s014lbl.pdf
03/31/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050810s007lbl.pdf
04/27/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050810lbl.pdf

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