Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020080
Company: GLAXOSMITHKLINE
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SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;SUBCUTANEOUS | Discontinued | None | Yes | No |
| 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 |
|---|---|---|---|---|---|
| 12/09/2025 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020080s055,020132s031,020626s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020080Orig1s055;020132Orig1s031;020626Orig1s029ltr.pdf | |
| 12/20/2021 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020080s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020080Orig1s054ltr.pdf | |
| 03/23/2021 | SUPPL-53 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020080Orig1s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020080Orig1s053ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/09/2025 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020080s055,020132s031,020626s029lbl.pdf | |
| 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 |
IMITREX
There are no Therapeutic Equivalents.
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 | 213518 | ALEMBIC |
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 | 213518 | ALEMBIC |
| SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AB | 090495 | DR REDDYS |
| SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AB | 090358 | SUN PHARM |