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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050810
Company: THEA PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZASITE AZITHROMYCIN 1% SOLUTION/DROPS;OPHTHALMIC Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/25/2024 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050810s017lbl.pdf
11/17/2021 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050810Orig1s019lbl.pdf
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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