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FDA ANDA · ANDA064046

BACITRACIN ZINC AND POLYMYXIN B SULFATE

Sponsor: BAUSCH AND LOMB INC

APPLICATION
ANDA064046
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-26
LATEST ACTION
2002-08-05
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

BACITRACIN ZINC AND POLYMYXIN B SULFATEPrescription
BACITRACIN ZINC 500 UNITS/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC

Approval history

2002-08-05Manufacturing (CMC) · Supplement 11AP
2001-11-27Manufacturing (CMC) · Supplement 10AP
2001-03-07Manufacturing (CMC) · Supplement 9AP
2000-06-27Manufacturing (CMC) · Supplement 8AP
2000-04-28Manufacturing (CMC) · Supplement 7AP
1999-06-07Manufacturing (CMC) · Supplement 6AP
1999-05-26Manufacturing (CMC) · Supplement 5AP
1998-10-22Manufacturing (CMC) · Supplement 4AP
1998-05-04Manufacturing (CMC) · Supplement 3AP
1996-06-20Manufacturing (CMC) · Supplement 2AP
1996-01-31Manufacturing (CMC) · Supplement 1AP
1995-01-26OriginalAP
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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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