APPLICATION
NDA050339
TYPE
NDA
ORIGINAL APPROVAL
1964-09-04
LATEST ACTION
1983-02-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ALBAMYCINDiscontinued
NOVOBIOCIN SODIUM EQ 250MG BASE · CAPSULE · ORAL
Approval history
1983-02-17Manufacturing (CMC) · Supplement 1AP
1982-08-24Manufacturing (CMC) · Supplement 37AP
1982-06-24Labeling · Supplement 36AP
1982-02-22Manufacturing (CMC) · Supplement 35AP
1979-04-27Labeling · Supplement 34AP
1979-04-03Manufacturing (CMC) · Supplement 33AP
1978-03-24Manufacturing (CMC) · Supplement 32AP
1976-11-24Manufacturing (CMC) · Supplement 31AP
1975-04-01Manufacturing (CMC) · Supplement 30AP
1974-11-26Labeling · Supplement 29AP
1973-06-08Labeling · Supplement 27AP
1973-06-08Manufacturing (CMC) · Supplement 28AP
1972-05-04Labeling · Supplement 26AP
1971-12-17Labeling · Supplement 25AP
1970-10-12Manufacturing (CMC) · Supplement 24AP
1970-07-21Labeling · Supplement 23AP
1970-04-20Labeling · Supplement 22AP
1970-03-27Manufacturing (CMC) · Supplement 19AP
1970-03-27Labeling · Supplement 21AP
1970-02-10Manufacturing (CMC) · Supplement 20AP
1969-11-26Labeling · Supplement 18AP
1969-11-14Manufacturing (CMC) · Supplement 17AP
1969-10-06Labeling · Supplement 16AP
1969-08-05Labeling · Supplement 14AP
1969-06-30Labeling · Supplement 15AP
1969-06-05Manufacturing (CMC) · Supplement 13AP
1969-03-14Manufacturing (CMC) · Supplement 12AP
1968-08-08Manufacturing (CMC) · Supplement 11AP
1967-08-07Labeling · Supplement 10AP
1967-03-20Labeling · Supplement 9AP
1966-12-15Labeling · Supplement 8AP
1966-11-25Manufacturing (CMC) · Supplement 7AP
1966-09-19Labeling · Supplement 6AP
1966-02-25Labeling · Supplement 5AP
1965-01-22Labeling · Supplement 4AP
1964-11-06Labeling · Supplement 3AP
1964-10-08Manufacturing (CMC) · Supplement 2AP
1964-09-04UNKNOWN · Original · unknownAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.