Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/28/1992 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/17/2018 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020080s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020080Orig1s052ltr.pdf
12/14/2017 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020080s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020080Orig1s050,020132Orig1s029,020626Origs027ltr.pdf
11/19/2015 SUPPL-49 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020080Orig1s049ltr.pdf
06/11/2015 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020080Orig1s048ltr.pdf
10/02/2012 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf
10/02/2012 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf
10/02/2012 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf
10/02/2012 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf
07/21/2010 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020080s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020080s038ltr.pdf
02/01/2006 SUPPL-36 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020080s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020080s036ltr.pdf
07/28/2003 SUPPL-30 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/2003/020080_S030_IMITREX TABLETS, NASAL SPRAY INJ.pdf
01/03/2003 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20080slr029ltr.pdf
02/02/2001 SUPPL-27 Labeling

Label is not available on this site.

02/02/2001 SUPPL-26 Labeling

Label is not available on this site.

02/02/2001 SUPPL-25 Labeling

Label is not available on this site.

02/02/2001 SUPPL-24 Labeling

Label is not available on this site.

11/26/1997 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/02/2001 SUPPL-21 Labeling

Label is not available on this site.

03/28/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/29/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/05/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/23/1996 SUPPL-5 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020080ap.pdf
05/22/1996 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

08/17/1994 SUPPL-3 Labeling

Label is not available on this site.

09/30/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

IMITREX

INJECTABLE;SUBCUTANEOUS; EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AP 020080 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 202758 AUROBINDO PHARMA LTD
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 079242 FRESENIUS KABI USA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 200183 HIKMA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 090314 MYLAN ASI
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 090641 MYLAN ASI
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 203322 MYLAN LABS LTD
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 077332 PAR PHARM
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 077871 PAR STERILE PRODUCTS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 077907 TEVA PHARMS USA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 079123 WEST-WARD PHARMS INT
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 078593 WOCKHARDT

IMITREX STATDOSE

INJECTABLE;SUBCUTANEOUS; EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX STATDOSE SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AB 020080 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AB 078319 ANTARES PHARMA INC

INJECTABLE;SUBCUTANEOUS; EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX STATDOSE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AB 020080 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AB 078319 ANTARES PHARMA INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AB 090495 DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AB 090358 SUN PHARMA GLOBAL

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