APPLICATION
NDA050317
TYPE
NDA
ORIGINAL APPROVAL
1964-12-29
LATEST ACTION
2022-04-11
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCONJUNCTIVAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LINCOCIN · ReferencePrescription
LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML · INJECTABLE · INJECTION
Approval history
2002-10-17Manufacturing (CMC) · Supplement 164AP
2001-10-30Manufacturing (CMC) · Supplement 163AP
2000-04-03Manufacturing (CMC) · Supplement 162AP
1998-10-28Labeling · Supplement 12AP
1993-01-15Manufacturing (CMC) · Supplement 14AP
1991-08-29Labeling · Supplement 13AP
1991-07-16Labeling · Supplement 18AP
1990-03-22Labeling · Supplement 11AP
1987-04-04Labeling · Supplement 161AP
1986-06-04Labeling · Supplement 9AP
1985-06-21Labeling · Supplement 8AP
1985-06-03Labeling · Supplement 7AP
1984-11-19Labeling · Supplement 6AP
1982-11-23Labeling · Supplement 5AP
1982-11-15Labeling · Supplement 4AP
1982-10-28Labeling · Supplement 3AP
1982-10-20Labeling · Supplement 2AP
1982-10-10Labeling · Supplement 1AP
1982-09-08Labeling · Supplement 158AP
1982-08-03Labeling · Supplement 157AP
1981-09-17Manufacturing (CMC) · Supplement 155AP
1980-12-09Manufacturing (CMC) · Supplement 154AP
1980-10-09Labeling · Supplement 153AP
1980-09-09Labeling · Supplement 152AP
1980-07-30Manufacturing (CMC) · Supplement 151AP
1980-04-30Labeling · Supplement 150AP
1979-08-24Manufacturing (CMC) · Supplement 149AP
1979-06-20Labeling · Supplement 148AP
1979-03-22Labeling · Supplement 147AP
1979-02-27Labeling · Supplement 145AP
1979-02-27Manufacturing (CMC) · Supplement 146AP
1978-07-10Labeling · Supplement 144AP
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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