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FDA ANDA · ANDA077051

FENTANYL-75

Sponsor: LAVIPHARM LABS

APPLICATION
ANDA077051
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-04
LATEST ACTION
2010-12-15
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

FENTANYL-75Discontinued
FENTANYL 75MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-25Discontinued
FENTANYL 25MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-100Discontinued
FENTANYL 100MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-50Discontinued
FENTANYL 50MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2010-12-15Labeling · Supplement 5AP
2008-01-09Manufacturing (CMC) · Supplement 1AP
2006-08-04Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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