APPLICATION
ANDA075233
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-24
LATEST ACTION
2006-07-24
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 0.05MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2006-07-24Labeling · Supplement 12AP
2005-10-06Labeling · Supplement 11AP
2005-03-04Labeling · Supplement 10AP
2005-01-21Labeling · Supplement 9AP
2005-01-06Labeling · Supplement 7AP
2002-12-23Manufacturing (CMC) · Supplement 3AP
2002-12-23Manufacturing (CMC) · Supplement 4AP
2001-10-25Labeling · Supplement 2AP
2000-11-20Manufacturing (CMC) · Supplement 1AP
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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