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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020080
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMITREX SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription AP Yes Yes
IMITREX STATDOSE SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription AB Yes Yes
IMITREX STATDOSE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2021 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020080s054lbl.pdf
03/23/2021 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020080Orig1s053lbl.pdf
03/23/2021 SUPPL-53 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020080Orig1s053lbl.pdf
07/17/2018 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020080s052lbl.pdf
12/14/2017 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020080s050lbl.pdf
11/19/2015 SUPPL-49 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s049lbl.pdf
06/11/2015 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s048lbl.pdf
10/02/2012 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf
10/02/2012 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf
10/02/2012 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf
10/02/2012 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf
07/21/2010 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020080s038lbl.pdf
02/01/2006 SUPPL-36 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020080s036lbl.pdf
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