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FDA ANDA · ANDA064047

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

neomycin sulfate, polymyxin b sulfate and gramicidin

Sponsor: BAUSCH AND LOMB INC

APPLICATION
ANDA064047
TYPE
ANDA
ORIGINAL APPROVAL
1996-01-31
LATEST ACTION
2001-11-27
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINPrescription
GRAMICIDIN 0.025MG/ML, NEOMYCIN SULFATE EQ 1.75MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SOLUTION/DROPS · OPHTHALMIC

Approval history

2001-11-27Manufacturing (CMC) · Supplement 13AP
2001-10-30Manufacturing (CMC) · Supplement 14AP
2001-04-30Manufacturing (CMC) · Supplement 12AP
2001-03-07Manufacturing (CMC) · Supplement 11AP
2000-06-27Manufacturing (CMC) · Supplement 10AP
2000-05-18Manufacturing (CMC) · Supplement 8AP
2000-04-28Manufacturing (CMC) · Supplement 9AP
1999-06-07Manufacturing (CMC) · Supplement 7AP
1999-02-19Manufacturing (CMC) · Supplement 6AP
1998-11-19Manufacturing (CMC) · Supplement 5AP
1998-10-22Manufacturing (CMC) · Supplement 4AP
1998-02-24Manufacturing (CMC) · Supplement 2AP
1998-02-24Manufacturing (CMC) · Supplement 3AP
1997-10-20Manufacturing (CMC) · Supplement 1AP
1996-01-31OriginalAP
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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