Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204158
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 10/27/2015 | 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 |
|---|---|---|---|---|---|
| 02/12/2020 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/12/2020 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/12/2020 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
LAMOTRIGINE
TABLET, ORALLY DISINTEGRATING;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |
TABLET, ORALLY DISINTEGRATING;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |
TABLET, ORALLY DISINTEGRATING;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |
TABLET, ORALLY DISINTEGRATING;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |