Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020132
Company: GLAXOSMITHKLINE
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 |
|---|---|---|---|---|---|
| 03/23/2021 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020132s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020132Orig1s030ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/23/2021 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020132s030lbl.pdf | |
| 03/23/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020132s030lbl.pdf | |
| 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 | 078327 | AUROBINDO PHARMA |
| SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 200263 | COREPHARMA |
| 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 | ORBION PHARMS |
| 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 | 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 | 078327 | AUROBINDO PHARMA |
| SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 200263 | COREPHARMA |
| 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 | ORBION PHARMS |
| 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 | 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 | 078327 | AUROBINDO PHARMA |
| SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 200263 | COREPHARMA |
| 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 | ORBION PHARMS |
| 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 | 076933 | WATSON LABS |