Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206382
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 06/17/2016 | 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 |
|---|---|---|---|---|---|
| 07/28/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2020 | SUPPL-3 | 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 |