APPLICATION
ANDA062251
TYPE
ANDA
ORIGINAL APPROVAL
1980-06-05
LATEST ACTION
2022-02-15
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GENTAMICIN SULFATEPrescription
GENTAMICIN SULFATE EQ 10MG BASE/ML · INJECTABLE · INJECTION
GENTAMICIN SULFATEPrescription
GENTAMICIN SULFATE EQ 40MG BASE/ML · INJECTABLE · INJECTION
Approval history
2022-02-15Labeling · Supplement 30 · standardAP
2001-07-23Manufacturing (CMC) · Supplement 28AP
2001-07-23Manufacturing (CMC) · Supplement 26AP
2001-07-23Manufacturing (CMC) · Supplement 27AP
1999-10-14Manufacturing (CMC) · Supplement 25AP
1999-02-11Manufacturing (CMC) · Supplement 24AP
1994-02-03Manufacturing (CMC) · Supplement 21AP
1993-09-16Manufacturing (CMC) · Supplement 20AP
1991-11-18Manufacturing (CMC) · Supplement 19AP
1991-05-31Manufacturing (CMC) · Supplement 17AP
1991-05-17Manufacturing (CMC) · Supplement 18AP
1991-02-08Manufacturing (CMC) · Supplement 16AP
1990-11-19Manufacturing (CMC) · Supplement 15AP
1988-07-12Manufacturing (CMC) · Supplement 14AP
1988-02-22Manufacturing (CMC) · Supplement 13AP
1987-05-22Manufacturing (CMC) · Supplement 11AP
1980-06-05OriginalAP
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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