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FDA NDA · NDA050526

STATICIN

Sponsor: WESTWOOD SQUIBB

APPLICATION
NDA050526
TYPE
NDA
ORIGINAL APPROVAL
1980-06-03
LATEST ACTION
2002-12-15
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

STATICIN · ReferenceDiscontinued
ERYTHROMYCIN 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL

Approval history

2002-12-15Labeling · Supplement 10 · standard — Letter ↗AP
1995-03-13Labeling · Supplement 9 · standardAP
1986-03-10Labeling · Supplement 2 · standardAP
1983-12-23Manufacturing (CMC) · Supplement 1 · standardAP
1982-03-24Manufacturing (CMC) · Supplement 8 · standardAP
1981-08-14Labeling · Supplement 5 · standardAP
1981-03-02Manufacturing (CMC) · Supplement 6 · standardAP
1981-03-02Manufacturing (CMC) · Supplement 7 · standardAP
1980-06-12Manufacturing (CMC) · Supplement 3 · standardAP
1980-06-12Manufacturing (CMC) · Supplement 4 · standardAP
1980-06-03Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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