APPLICATION
ANDA064211
TYPE
ANDA
ORIGINAL APPROVAL
1998-04-13
LATEST ACTION
2020-05-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEPrescription
POLYMYXIN B SULFATE 10,000 UNITS/ML, TRIMETHOPRIM SULFATE EQ 1MG BASE/ML · SOLUTION/DROPS · OPHTHALMIC
Approval history
2020-05-18Labeling · Supplement 16 · standardAP
2002-12-23Manufacturing (CMC) · Supplement 9AP
2002-10-01Manufacturing (CMC) · Supplement 8AP
2002-06-13Labeling · Supplement 7AP
2002-04-19Manufacturing (CMC) · Supplement 6AP
2001-10-05Labeling · Supplement 5AP
2000-08-15Manufacturing (CMC) · Supplement 3AP
2000-04-07Manufacturing (CMC) · Supplement 4AP
1999-11-29Labeling · Supplement 1AP
1999-10-26Manufacturing (CMC) · Supplement 2AP
1998-04-13OriginalAP
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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