Application Sponsors
| ANDA 076847 | DR REDDYS LABS INC | |
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 | 2 | AP | 2015-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-07-01 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-07-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
DR REDDYS LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 76847
[companyName] => DR REDDYS LABS INC
[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
)
)