ANDA 207763 | ZYDUS PHARMS |
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Prescription | 006 |
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 |
005 | TABLET, EXTENDED RELEASE;ORAL | 250MG | 0 | LAMOTRIGINE | LAMOTRIGINE |
006 | TABLET, EXTENDED RELEASE;ORAL | 300MG | 0 | LAMOTRIGINE | LAMOTRIGINE |
UNKNOWN; | ORIG | 1 | AP | 2020-04-01 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-03-10 | STANDARD |
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
006 | Prescription | AB |
cder:Array ( [0] => Array ( [ApplNo] => 207763 [companyName] => ZYDUS PHARMS [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"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"250MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}] [labels] => [originalApprovals] => [{"actionDate":"04\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}] [supplements] => [actionDate] => 2020-04-01 ) )