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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019726
Company: TERSERA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLADEX GOSERELIN ACETATE EQ 3.6MG BASE IMPLANT;IMPLANTATION Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/12/2015 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf
10/07/2014 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf
06/18/2013 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf
06/18/2013 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf
01/14/2011 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019726s054lbl.pdf
08/31/2009 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf
08/31/2009 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf
08/31/2009 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf
07/27/1998 SUPPL-24 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf
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