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FDA NDA · NDA018977

TRI-NORINYL 28-DAY

Sponsor: DR REDDYS LABS SA

APPLICATION
NDA018977
TYPE
NDA
ORIGINAL APPROVAL
1984-04-11
LATEST ACTION
2022-04-29
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

TRI-NORINYL 28-DAY · ReferencePrescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG,0.5MG · TABLET · ORAL-28
TRI-NORINYL 21-DAYDiscontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG,0.5MG · TABLET · ORAL-21

Approval history

2022-04-29Labeling · Supplement 43 · standard — Label ↗AP
2017-08-09Labeling · Supplement 41 · standard — Label ↗AP
2001-08-15Manufacturing (CMC) · Supplement 28 · standardAP
2000-02-14Manufacturing (CMC) · Supplement 26 · standardAP
2000-01-24Labeling · Supplement 27 · standardAP
1999-05-14Labeling · Supplement 24 · standardAP
1999-02-04Manufacturing (CMC) · Supplement 25 · standardAP
1997-07-30Manufacturing (CMC) · Supplement 23 · standardAP
1996-02-22Labeling · Supplement 22 · standardAP
1995-08-30Labeling · Supplement 19 · standardAP
1994-12-13Labeling · Supplement 20 · standardAP
1994-12-13Labeling · Supplement 21 · standardAP
1994-02-04Labeling · Supplement 17AP
1992-07-31Manufacturing (CMC) · Supplement 18 · standardAP
1990-09-27Labeling · Supplement 16AP
1990-09-19Manufacturing (CMC) · Supplement 15 · standardAP
1989-10-23Manufacturing (CMC) · Supplement 14 · standardAP
1989-10-23Manufacturing (CMC) · Supplement 13 · standardAP
1989-02-22Labeling · Supplement 10AP
1989-02-22Manufacturing (CMC) · Supplement 11 · standardAP
1989-02-03Manufacturing (CMC) · Supplement 12 · standardAP
1986-10-17Manufacturing (CMC) · Supplement 3 · standardAP
1986-07-17Labeling · Supplement 8AP
1985-10-25Labeling · Supplement 7AP
1985-04-16Labeling · Supplement 6AP
1984-12-05Labeling · Supplement 1AP
1984-11-13Manufacturing (CMC) · Supplement 4 · standardAP
1984-09-27Manufacturing (CMC) · Supplement 2 · standardAP
1984-04-11Type 3 - New Dosage Form · Original · standardAP
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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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