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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022377
Company: MERIDIAN MEDCL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALSUMA (AUTOINJECTOR) SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) SOLUTION;SUBCUTANEOUS Discontinued None No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/05/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf
06/05/2014 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf
06/05/2014 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf
06/29/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022377s000lbl.pdf
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