Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020626
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMITREX SUMATRIPTAN 5MG/SPRAY SPRAY;NASAL Prescription AB Yes Yes
IMITREX SUMATRIPTAN 10MG/SPRAY SPRAY;NASAL Discontinued None No No
IMITREX SUMATRIPTAN 20MG/SPRAY SPRAY;NASAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/26/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020626_imitrex_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/14/2017 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020626s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020080Orig1s050,020132Orig1s029,020626Origs027ltr.pdf
03/25/2016 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/25/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020132Orig1s028,020626Orig1s025ltr.pdf
03/01/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020626s018s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020626s018,s022ltr.pdf
03/01/2012 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020626s018,s022ltr.pdf
07/21/2010 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf
07/21/2010 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf
07/21/2010 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf
07/28/2003 SUPPL-7 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20132slr014,20626slr007,20080slr030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020626_S007_IMITREX TABLETS, NASAL SPRAY INJECTION.pdf
05/10/2002 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20626s6ltr.pdf
10/13/2004 SUPPL-4 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20626s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20626s004ltr.pdf
12/11/2000 SUPPL-3 Labeling

Label is not available on this site.

06/01/2000 SUPPL-2 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020626_s002_IMITREX_NASAL_SPRAY.pdf
06/01/2000 SUPPL-1 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020626_s001_IMITREX_NASAL_SPRAY.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/14/2017 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020626s027lbl.pdf
11/25/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf
03/01/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020626s018s022lbl.pdf
07/21/2010 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf
07/21/2010 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf
07/21/2010 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf
10/13/2004 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20626s004lbl.pdf

IMITREX

SPRAY;NASAL; 5MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN 5MG/SPRAY SPRAY;NASAL Prescription Yes AB 020626 GLAXOSMITHKLINE
SUMATRIPTAN SUMATRIPTAN 5MG/SPRAY SPRAY;NASAL Prescription No AB 204841 LANNETT CO INC

SPRAY;NASAL; 20MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN 20MG/SPRAY SPRAY;NASAL Prescription Yes AB 020626 GLAXOSMITHKLINE
SUMATRIPTAN SUMATRIPTAN 20MG/SPRAY SPRAY;NASAL Prescription No AB 204841 LANNETT CO INC

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