Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078009
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMOTRIGINE | LAMOTRIGINE | 2MG | TABLET, CHEWABLE; ORAL | Prescription | None | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 01/22/2009 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078009Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/10/2022 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/10/2022 | SUPPL-28 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/14/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/14/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/07/2012 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
||
| 09/29/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2010 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/23/2010 | SUPPL-3 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
| 06/23/2010 | SUPPL-1 | Labeling |
Label is not available on this site. |
LAMOTRIGINE
TABLET, FOR SUSPENSION;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL CD | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020764 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 201168 | ALEMBIC |
| LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 090401 | AUROBINDO PHARMA |
| LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076701 | DR REDDYS LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079099 | GLENMARK PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079204 | TARO |
| LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076928 | WATSON LABS |
| LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 078009 | ZYDUS PHARMS USA INC |
TABLET, FOR SUSPENSION;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL CD | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020764 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 201168 | ALEMBIC |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 090401 | AUROBINDO PHARMA |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076701 | DR REDDYS LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079099 | GLENMARK PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079204 | TARO |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076928 | WATSON LABS |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 078009 | ZYDUS PHARMS USA INC |