Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077051
Company: LAVIPHARM LABS

• Other Important Information from FDA

Products on ANDA 077051

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENTANYL-100	FENTANYL	100MCG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
FENTANYL-25	FENTANYL	25MCG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
FENTANYL-50	FENTANYL	50MCG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
FENTANYL-75	FENTANYL	75MCG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077051

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2006	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
12/15/2010	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
01/09/2008	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.