Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020132
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMITREX SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription AB Yes Yes
IMITREX SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription AB Yes No
IMITREX SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription AB Yes 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
06/01/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/14/2017 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020132s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020080Orig1s050,020132Orig1s029,020626Origs027ltr.pdf
11/25/2013 SUPPL-28 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-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020132s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020132s024,s026ltr.pdf
03/01/2012 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020132s024,s026ltr.pdf
08/11/2010 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf
08/11/2010 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf
08/11/2010 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf
06/17/2004 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20132slr018ltr.pdf
06/30/2003 SUPPL-15 Manufacturing (CMC)-Formulation, Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020132_s015_ImitrexTOC.cfm
07/28/2003 SUPPL-14 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/2003/020132_S014_IMITREX TABLETS, NASAL SPRAY INJ.pdf
08/11/2010 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf
06/25/2001 SUPPL-12 Labeling

Label is not available on this site.

06/25/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/09/2001 SUPPL-10 Labeling

Label is not available on this site.

02/09/2001 SUPPL-8 Labeling

Label is not available on this site.

02/09/2001 SUPPL-7 Labeling

Label is not available on this site.

02/24/1998 SUPPL-6 Labeling

Label is not available on this site.

12/16/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/13/1998 SUPPL-3 Efficacy-New Dosing Regimen

Label is not available on this site.

03/28/1996 SUPPL-1 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
12/14/2017 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020132s029lbl.pdf
11/25/2013 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf
03/01/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020132s024s026lbl.pdf
08/11/2010 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf
08/11/2010 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf
08/11/2010 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf
08/11/2010 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf

IMITREX

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription Yes AB 020132 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription No AB 200263 APOTEX INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription No AB 078327 AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription No AB 076847 DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription No AB 077744 MYLAN
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription No AB 078284 ORCHID HLTHCARE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription No AB 078295 SUN PHARM INDS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription No AB 076572 SUN PHARM INDS LTD
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET;ORAL Prescription No AB 076933 WATSON LABS

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 020132 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 200263 APOTEX INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 078327 AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 076847 DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 077744 MYLAN
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 078284 ORCHID HLTHCARE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 078295 SUN PHARM INDS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 076554 SUN PHARM INDS LTD
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 076933 WATSON LABS

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription Yes AB 020132 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 200263 APOTEX INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 078327 AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 076847 DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 077744 MYLAN
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 078284 ORCHID HLTHCARE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 078295 SUN PHARM INDS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 076554 SUN PHARM INDS LTD
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 076933 WATSON LABS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English