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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050207
Company: CARNEGIE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
E.E.S. ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE;ORAL Prescription AB Yes No
ERYPED ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE;ORAL Prescription AB Yes Yes
ERYPED ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE;ORAL Prescription AB Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/23/2018 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050207s074,050611s036lbl.pdf
08/17/2017 SUPPL-73 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/2017/050207s073lbl.pdf
02/02/2012 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050207s071lbl.pdf
01/26/2011 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050207s064lbl.pdf
12/10/2008 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.pdf
01/05/2008 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050207s065lbl.pdf
08/10/2006 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.pdf
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