Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Prescription | 006 |
Application Products
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 |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2012-12-26 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
006 | Prescription | AB |
CDER Filings
ANCHEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 201374
[companyName] => ANCHEN 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":"12\/26\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/201374Orig1s000Approv.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2012-12-26
)
)