Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077744
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | No | No |
SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET;ORAL | Prescription | AB | No | No |
SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
08/10/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077744s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/31/2023 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/01/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
04/16/2019 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
06/19/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
06/19/2015 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/11/2012 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
SUMATRIPTAN SUCCINATE
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 |
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 |