Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078134
Company: HIKMA PHARMS

Products on ANDA 078134

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078134

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-Package Insert, Labeling-Medication Guide		Label is not available on this site.
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.
12/14/2014	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		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.