Documents
Application Sponsors
ANDA 078295 | SUN PHARM INDS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | EQ 25MG BASE | 0 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE |
002 | TABLET;ORAL | EQ 50MG BASE | 0 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE |
003 | TABLET;ORAL | EQ 100MG BASE | 0 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE |
FDA Submissions
| ORIG | 1 | AP | 2009-08-10 | |
LABELING; Labeling | SUPPL | 7 | AP | 2015-05-01 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2019-05-17 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2020-04-13 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 8 | Null | 7 |
SUPPL | 18 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
SUN PHARM INDS
cder:Array
(
[0] => Array
(
[ApplNo] => 78295
[companyName] => SUN PHARM INDS
[docInserts] => ["",""]
[products] => [{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SUMATRIPTAN SUCCINATE","submission":"SUMATRIPTAN SUCCINATE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SUMATRIPTAN SUCCINATE","submission":"SUMATRIPTAN SUCCINATE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SUMATRIPTAN SUCCINATE","submission":"SUMATRIPTAN SUCCINATE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)