Application Sponsors
| ANDA 202383 | DR REDDYS LABS LTD | |
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 | 300MG | 0 | LAMOTRIGINE | LAMOTRIGINE |
| 006 | TABLET, EXTENDED RELEASE;ORAL | 250MG | 0 | LAMOTRIGINE | LAMOTRIGINE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2013-06-19 | |
| SUPPL | 2 | TA | 2015-10-01 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2015-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2015-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2020-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2021-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-11-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202383
[companyName] => DR REDDYS LABS LTD
[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":"300MG","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"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/19\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/09\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/09\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/24\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/24\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/24\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/01\/2015","submission":"SUPPL-2","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-06-09
)
)