Drugs@FDA: FDA Approved Drug Products

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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 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/29/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022377s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022377s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022377_alsuma_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022377Orig1s000SumR.pdf
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004ltr.pdf
04/15/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/05/2014 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004ltr.pdf
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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