APPLICATION
ANDA062351
TYPE
ANDA
ORIGINAL APPROVAL
1982-02-18
LATEST ACTION
2009-12-04
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
GENTAMICIN SULFATEPrescription
GENTAMICIN SULFATE EQ 0.1% BASE · OINTMENT · TOPICAL
Approval history
2009-12-04Labeling · Supplement 20AP
2009-04-17Labeling · Supplement 19AP
2003-05-21Labeling · Supplement 17AP
2002-11-26Manufacturing (CMC) · Supplement 16AP
2002-03-14Manufacturing (CMC) · Supplement 15AP
1993-05-21Labeling · Supplement 14AP
1987-07-13Manufacturing (CMC) · Supplement 13AP
1982-02-18OriginalAP
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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