ANDA 203370 | TORRENT |
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
001 | TABLET, EXTENDED RELEASE;ORAL | 25MG | 0 | LAMOTRIGINE | LAMOTRIGINE |
002 | TABLET, EXTENDED RELEASE;ORAL | 50MG | 0 | LAMOTRIGINE | LAMOTRIGINE |
003 | TABLET, EXTENDED RELEASE;ORAL | 100MG | 0 | LAMOTRIGINE | LAMOTRIGINE |
004 | TABLET, EXTENDED RELEASE;ORAL | 200MG | 0 | LAMOTRIGINE | LAMOTRIGINE |
UNKNOWN; | ORIG | 1 | AP | 2013-12-23 | |
LABELING; Labeling | SUPPL | 2 | AP | 2017-04-25 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2017-04-25 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2019-11-21 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2019-11-21 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2021-02-19 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2021-11-09 | STANDARD |
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 12 | Null | 15 |
SUPPL | 13 | Null | 15 |
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
cder:Array ( [0] => Array ( [ApplNo] => 203370 [companyName] => TORRENT [docInserts] => ["",""] [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"50MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}] [labels] => [originalApprovals] => [{"actionDate":"12\/23\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}] [supplements] => [{"actionDate":"11\/21\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/21\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/25\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/25\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}] [actionDate] => 2019-11-21 ) )