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FDA NDA · NDA020874

LUNELLE

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APPLICATION
NDA020874
TYPE
NDA
ORIGINAL APPROVAL
2000-10-05
LATEST ACTION
2002-04-26
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

LUNELLE · ReferenceDiscontinued
ESTRADIOL CYPIONATE 5MG/0.5ML, MEDROXYPROGESTERONE ACETATE 25MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAMUSCULAR

Approval history

2002-04-26Manufacturing (CMC) · Supplement 2 · standardAP
2001-06-07Manufacturing (CMC) · Supplement 1 · standardAP
2000-10-05Type 4 - New Combination · Original · standard — 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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