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FDA NDA · NDA050801

EVOCLIN

Sponsor: NORVIUM BIOSCIENCE

APPLICATION
NDA050801
TYPE
NDA
ORIGINAL APPROVAL
2004-10-22
LATEST ACTION
2018-04-17
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Discontinued

Products

EVOCLIN · ReferenceDiscontinued
CLINDAMYCIN PHOSPHATE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · AEROSOL, FOAM · TOPICAL

Approval history

2018-04-17Labeling · Supplement 18 · standard — Label ↗AP
2015-01-20Manufacturing (CMC) · Supplement 16 · standardAP
2012-01-20Labeling · Supplement 15 · standard — Label ↗AP
2010-12-21Labeling · Supplement 11 · unknown — Letter ↗AP
2006-07-11Labeling · Supplement 6 · standard — Label ↗AP
2004-10-22Type 3 - New Dosage Form · Original · standard — Label ↗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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