Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050405
Company: PRAGMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEFLEX CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Discontinued None Yes No
KEFLEX CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Discontinued None Yes No
KEFLEX CEPHALEXIN EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
KEFLEX CEPHALEXIN EQ 750MG BASE CAPSULE;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2018 SUPPL-108 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050405s108lbl.pdf
12/18/2018 SUPPL-107 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050405s107lbl.pdf
10/30/2015 SUPPL-106 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/2015/050405s106lbl.pdf
05/12/2006 SUPPL-97 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050405s097lbl.pdf
01/15/2004 SUPPL-94 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50405slr094_keflex_lbl.pdf

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