Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076918
Company: TARO PHARM INDS

Products on ANDA 076918

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUCONAZOLE	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No
FLUCONAZOLE	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076918

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2006	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
08/27/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/27/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/27/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/18/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/25/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/06/2008	SUPPL-1	Labeling		Label is not available on this site.