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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050670
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZITHROMAX AZITHROMYCIN EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/22/2021 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050670s036,050710s051,050711s050,050784s037lbl.pdf
04/24/2019 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050670s034lbl.pdf
03/30/2017 SUPPL-32 Labeling-Package Insert 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/2017/050670s032,050710s046,050711s043,050784s030lbl.pdf
10/25/2007 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf
03/24/2004 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf
11/13/2000 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf
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