Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078318
Company: TEVA PARENTERAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE;SUBCUTANEOUS Discontinued None No No
SUMATRIPTAN SUCCINATE 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
07/29/2008 ORIG-1 Tentative Approval Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078318Orig1s000LBL.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/29/2008 ORIG-1 Tentative Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078318Orig1s000LBL.pdf

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