Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203733
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMOTRIGINE | LAMOTRIGINE | 250MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/13/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/21/2019 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/21/2019 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/14/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LAMOTRIGINE
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 | 203733 | 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 | 201374 | ANCHEN 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 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
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