Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207497
Company: AMNEAL PHARMS
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 |
|---|---|---|---|---|---|
| 12/26/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 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 | 201374 | PH HEALTH |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | SCIEGEN PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203370 | TORRENT |
| 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 | 201374 | PH HEALTH |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | SCIEGEN PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203370 | TORRENT |
| 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 | 201374 | PH HEALTH |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202887 | RUBICON RESEARCH |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | SCIEGEN PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203370 | TORRENT |
| 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 | 211821 | ALEMBIC |
| 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 | 201374 | PH HEALTH |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202887 | RUBICON RESEARCH |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | SCIEGEN PHARMS |
| 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 | 211821 | ALEMBIC |
| 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 | 201374 | PH HEALTH |
| 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 | 211821 | ALEMBIC |
| 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 | 201374 | PH HEALTH |
| LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202498 | SCIEGEN PHARMS |
| 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 |