Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090906
Company: LOTUS PHARM CO LTD
Company: LOTUS PHARM CO LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Discontinued | None | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/2010 | 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 |
|---|---|---|---|---|---|
| 12/26/2015 | SUPPL-7 | Labeling-Proprietary Name Change |
Label is not available on this site. |
||
| 11/24/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2016 | SUPPL-2 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/090906Orig1s002ltr.pdf |