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FDA NDA · NDA016672

OVRAL

Sponsor: WYETH PHARMS

APPLICATION
NDA016672
TYPE
NDA
ORIGINAL APPROVAL
1968-04-16
LATEST ACTION
2002-03-06
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OVRALDiscontinued
ETHINYL ESTRADIOL 0.05MG, NORGESTREL 0.5MG · TABLET · ORAL-21

Approval history

2002-03-06Manufacturing (CMC) · Supplement 50 · priorityAP
2001-03-23Labeling · Supplement 46 · standard — Review ↗AP
1998-07-08Manufacturing (CMC) · Supplement 48 · priorityAP
1997-08-14Labeling · Supplement 47 · standard — Review ↗AP
1994-11-29Labeling · Supplement 45 · standardAP
1994-01-28Labeling · Supplement 44 · standardAP
1993-12-23Manufacturing (CMC) · Supplement 43 · priorityAP
1990-08-08Labeling · Supplement 40AP
1989-04-18Manufacturing (CMC) · Supplement 42 · priorityAP
1988-10-19Manufacturing (CMC) · Supplement 34 · priorityAP
1988-04-27Manufacturing (CMC) · Supplement 41 · priorityAP
1986-07-15Labeling · Supplement 38AP
1986-02-19Manufacturing (CMC) · Supplement 37 · priorityAP
1986-01-07Manufacturing (CMC) · Supplement 35 · priorityAP
1985-10-16Labeling · Supplement 36AP
1985-02-19Manufacturing (CMC) · Supplement 32 · priorityAP
1984-07-26Labeling · Supplement 33AP
1980-02-21Manufacturing (CMC) · Supplement 28 · priorityAP
1978-12-07Labeling · Supplement 19AP
1977-11-22Labeling · Supplement 25AP
1968-04-16Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priorityAP
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