APPLICATION
NDA050594
TYPE
NDA
ORIGINAL APPROVAL
1985-02-15
LATEST ACTION
1998-07-23
ROUTE
TOPICAL
DOSAGE FORM
SWAB
MARKETING STATUS
Discontinued
Products
ERYCETTE · ReferenceDiscontinued
ERYTHROMYCIN 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SWAB · TOPICAL
Approval history
1998-07-23Manufacturing (CMC) · Supplement 23 · standardAP
1997-04-30Manufacturing (CMC) · Supplement 21 · standardAP
1997-03-07Manufacturing (CMC) · Supplement 22 · standardAP
1995-12-15Manufacturing (CMC) · Supplement 20 · standardAP
1995-06-08Labeling · Supplement 19 · standardAP
1995-01-05Manufacturing (CMC) · Supplement 18 · standardAP
1993-02-18Manufacturing (CMC) · Supplement 17 · standardAP
1992-12-01Manufacturing (CMC) · Supplement 16 · standardAP
1992-01-15Manufacturing (CMC) · Supplement 15 · standardAP
1990-08-08Labeling · Supplement 13AP
1987-12-14Manufacturing (CMC) · Supplement 12 · standardAP
1987-10-06Manufacturing (CMC) · Supplement 11 · standardAP
1987-01-28Labeling · Supplement 3AP
1986-10-09Manufacturing (CMC) · Supplement 8 · standardAP
1986-09-03Manufacturing (CMC) · Supplement 7 · standardAP
1986-07-18Manufacturing (CMC) · Supplement 6 · standardAP
1986-01-13Manufacturing (CMC) · Supplement 5 · standardAP
1985-12-12Manufacturing (CMC) · Supplement 4 · standardAP
1985-09-19Manufacturing (CMC) · Supplement 2 · standardAP
1985-05-08Manufacturing (CMC) · Supplement 1 · standardAP
1985-02-15Type 5 - New Formulation or New Manufacturer · 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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