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FDA ANDA · ANDA064064

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

neomycin sulfate, polymyxin b sulfate and bacitracin zinc

Sponsor: BAUSCH AND LOMB INC

APPLICATION
ANDA064064
TYPE
ANDA
ORIGINAL APPROVAL
1995-10-30
LATEST ACTION
2002-02-05
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINCPrescription
BACITRACIN ZINC 400 UNITS/GM, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC

Approval history

2002-02-05Manufacturing (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
1999-03-30Manufacturing (CMC) · Supplement 3AP
1999-03-03Manufacturing (CMC) · Supplement 5AP
1998-12-29Manufacturing (CMC) · Supplement 4AP
1998-10-22Manufacturing (CMC) · Supplement 2AP
1996-03-15Manufacturing (CMC) · Supplement 1AP
1995-10-30OriginalAP
VIEW ON DRUGS@FDA ↗

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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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