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FDA NDA · NDA020860

LEVLITE

Sponsor: BAYER HLTHCARE

APPLICATION
NDA020860
TYPE
NDA
ORIGINAL APPROVAL
1998-07-13
LATEST ACTION
2001-12-17
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVLITE · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28
LEVLITE · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21

Approval history

2001-12-17Manufacturing (CMC) · Supplement 1 · standardAP
2001-12-17Manufacturing (CMC) · Supplement 2 · standardAP
1998-07-13Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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