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FDA ANDA · ANDA074538

TRIVORA-21

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA074538
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-18
LATEST ACTION
2022-04-29
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

TRIVORA-21Discontinued
ETHINYL ESTRADIOL 0.03MG,0.04MG,0.03MG, LEVONORGESTREL 0.05MG,0.075MG,0.125MG · TABLET · ORAL-21
TRIVORA-28Prescription
ETHINYL ESTRADIOL 0.03MG,0.04MG,0.03MG, LEVONORGESTREL 0.05MG,0.075MG,0.125MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 28 · standardAP
2022-02-22Labeling · Supplement 27 · standardAP
2017-08-09Labeling · Supplement 25 · standardAP
2007-04-03Labeling · Supplement 17 — Label ↗AP
1998-06-08Manufacturing (CMC) · Supplement 1AP
1998-02-10Manufacturing (CMC) · Supplement 2AP
1997-12-18Original — Review ↗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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