APPLICATION
NDA050584
TYPE
NDA
ORIGINAL APPROVAL
1985-01-10
LATEST ACTION
2001-02-28
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
AKNE-MYCIN · ReferenceDiscontinued
ERYTHROMYCIN 2% · OINTMENT · TOPICAL
Approval history
2001-02-28Manufacturing (CMC) · Supplement 5 · standardAP
1997-09-22Manufacturing (CMC) · Supplement 4 · standardAP
1995-07-14Manufacturing (CMC) · Supplement 2 · standardAP
1995-07-14Manufacturing (CMC) · Supplement 3 · standardAP
1985-04-23Labeling · Supplement 1AP
1985-01-10Type 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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