APPLICATION
ANDA040197
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-22
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 2MG · TABLET · ORAL
ESTRADIOLPrescription
ESTRADIOL 0.5MG · TABLET · ORAL
ESTRADIOLPrescription
ESTRADIOL 1MG · TABLET · ORAL
Approval history
2024-02-15Labeling · Supplement 33 · standardAP
2018-08-24Labeling · Supplement 27 · standardAP
2006-05-01Labeling · Supplement 15AP
2002-01-02Manufacturing (CMC) · Supplement 9AP
2001-06-22Manufacturing (CMC) · Supplement 10AP
1999-12-21Manufacturing (CMC) · Supplement 7AP
1999-09-24Labeling · Supplement 8AP
1999-05-20Manufacturing (CMC) · Supplement 6AP
1999-05-07Manufacturing (CMC) · Supplement 4AP
1999-05-07Labeling · Supplement 5AP
1998-12-01Manufacturing (CMC) · Supplement 2AP
1998-04-07Manufacturing (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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