Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 078134
Company: HIKMA PHARMS
Company: HIKMA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Discontinued | None | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 04/19/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078134Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/14/2014 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2014 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/17/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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