Drugs@FDA: FDA-Approved Drugs
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/30/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/11/2021 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
06/09/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
06/09/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
LAMOTRIGINE
TABLET, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL XR | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022115 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200672 | ACTAVIS ELIZABETH |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207497 | AMNEAL PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202383 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201791 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203370 | TORRENT |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | WOCKHARDT BIO AG |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL XR | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022115 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200672 | ACTAVIS ELIZABETH |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207497 | AMNEAL PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202383 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201791 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203370 | TORRENT |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | WOCKHARDT BIO AG |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL XR | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022115 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200672 | ACTAVIS ELIZABETH |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207497 | AMNEAL PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202383 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201791 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202887 | RUBICON |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203370 | TORRENT |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | WOCKHARDT BIO AG |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL XR | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022115 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200672 | ACTAVIS ELIZABETH |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207497 | AMNEAL PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202383 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201791 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202887 | RUBICON |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | WOCKHARDT BIO AG |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL XR | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022115 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200672 | ACTAVIS ELIZABETH |
LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207497 | AMNEAL PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202383 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201791 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL XR | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022115 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200672 | ACTAVIS ELIZABETH |
LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207497 | AMNEAL PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202383 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201791 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | WOCKHARDT BIO AG |
LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |