Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076523
Company: HIKMA

Products on ANDA 076523

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEFLOQUINE HYDROCHLORIDE	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076523

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/01/2004	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
10/11/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/26/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076523s007lbl.pdf
08/15/2011	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/18/2009	SUPPL-5	Labeling-Medication Guide		Label is not available on this site.
10/20/2009	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/19/2009	SUPPL-3	Labeling		Label is not available on this site.
09/18/2008	SUPPL-2	Labeling		Label is not available on this site.

Labels for ANDA 076523

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076523s007lbl.pdf