← FDA DRUG APPROVALS
FDA ANDA · ANDA065006
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Sponsor: EPIC PHARMA LLC
APPLICATION
ANDA065006
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-17
LATEST ACTION
1999-03-05
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
1999-03-05Manufacturing (CMC) · Supplement 1AP
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.