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FDA NDA · NDA018751

SPECTAZOLE

Sponsor: ALVOGEN

APPLICATION
NDA018751
TYPE
NDA
ORIGINAL APPROVAL
1982-12-23
LATEST ACTION
2020-01-21
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

SPECTAZOLE · ReferenceDiscontinued
ECONAZOLE NITRATE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2020-01-21Labeling · Supplement 25 · standard — Letter ↗AP
2017-09-07Manufacturing (CMC) · Supplement 24 — Label ↗AP
2014-03-28Labeling · Supplement 23 · standard — Label ↗AP
2001-07-11Manufacturing (CMC) · Supplement 19 · standardAP
2001-04-04Manufacturing (CMC) · Supplement 18 · standardAP
2001-03-20Manufacturing (CMC) · Supplement 17 · standardAP
1998-07-23Manufacturing (CMC) · Supplement 16 · standardAP
1995-11-17Manufacturing (CMC) · Supplement 12 · standardAP
1995-02-24Labeling · Supplement 11 · standardAP
1992-09-10Manufacturing (CMC) · Supplement 9 · standardAP
1990-04-25Labeling · Supplement 6AP
1990-03-09Manufacturing (CMC) · Supplement 8 · standardAP
1986-12-18Manufacturing (CMC) · Supplement 5 · standardAP
1985-06-28Manufacturing (CMC) · Supplement 4 · standardAP
1985-05-22Labeling · Supplement 1AP
1985-01-08Manufacturing (CMC) · Supplement 2 · standardAP
1982-12-23Type 1 - New Molecular Entity · 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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