Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
06/15/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
06/15/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
11/21/2019 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/21/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/14/2014 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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12/14/2014 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/14/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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05/17/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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09/29/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |