APPLICATION
NDA050617
TYPE
NDA
ORIGINAL APPROVAL
1987-10-21
LATEST ACTION
2002-12-19
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued
Products
ERYGEL · ReferenceDiscontinued
ERYTHROMYCIN 2% · GEL · TOPICAL
Approval history
2002-12-19Manufacturing (CMC) · Supplement 10 · standardAP
2000-12-11Manufacturing (CMC) · Supplement 9 · standardAP
1998-12-10Manufacturing (CMC) · Supplement 8 · standardAP
1997-08-08Manufacturing (CMC) · Supplement 7 · standardAP
1997-02-05Manufacturing (CMC) · Supplement 6 · standardAP
1995-04-12Labeling · Supplement 5 · standardAP
1995-01-03Manufacturing (CMC) · Supplement 4 · standardAP
1993-06-30Efficacy · Supplement 1AP
1993-03-18Labeling · Supplement 2AP
1987-10-21Type 3 - New Dosage Form · Original · standardAP
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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