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FDA ANDA · ANDA064120
POLYMYXIN B SULFATE AND TRIMETHOPRIM
polymyxin b sulfate and trimethoprim sulfate
Sponsor: BAUSCH AND LOMB INC
APPLICATION
ANDA064120
TYPE
ANDA
ORIGINAL APPROVAL
1997-02-14
LATEST ACTION
2002-06-13
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
2002-06-13Labeling · Supplement 16AP
2001-11-27Manufacturing (CMC) · Supplement 15AP
2001-06-21Manufacturing (CMC) · Supplement 14AP
2001-04-30Manufacturing (CMC) · Supplement 13AP
2001-03-07Manufacturing (CMC) · Supplement 12AP
2000-11-17Manufacturing (CMC) · Supplement 9AP
2000-09-11Labeling · Supplement 10AP
2000-06-27Manufacturing (CMC) · Supplement 11AP
2000-05-18Manufacturing (CMC) · Supplement 7AP
2000-04-28Manufacturing (CMC) · Supplement 8AP
1999-06-07Manufacturing (CMC) · Supplement 6AP
1999-04-13Manufacturing (CMC) · Supplement 5AP
1998-11-19Manufacturing (CMC) · Supplement 3AP
1998-08-05Manufacturing (CMC) · Supplement 4AP
1998-02-23Manufacturing (CMC) · Supplement 1AP
1998-02-23Manufacturing (CMC) · Supplement 2AP
1997-02-14OriginalAP
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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