← FDA DRUG APPROVALS

FDA ANDA · ANDA064053

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

neomycin sulfate, polymyxin b sulfate, hydrocortisone

Sponsor: BAUSCH AND LOMB INC

APPLICATION
ANDA064053
TYPE
ANDA
ORIGINAL APPROVAL
1995-12-29
LATEST ACTION
2006-07-03
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEPrescription
HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SOLUTION/DROPS · OTIC

Approval history

2006-07-03Labeling · Supplement 33AP
2002-04-17Manufacturing (CMC) · Supplement 24AP
2002-03-28Manufacturing (CMC) · Supplement 22AP
2002-03-15Manufacturing (CMC) · Supplement 19AP
2002-03-15Labeling · Supplement 23AP
2002-03-15Manufacturing (CMC) · Supplement 21AP
2001-11-27Manufacturing (CMC) · Supplement 20AP
2001-07-30Manufacturing (CMC) · Supplement 18AP
2001-03-07Manufacturing (CMC) · Supplement 17AP
2001-02-02Manufacturing (CMC) · Supplement 16AP
2001-01-31Manufacturing (CMC) · Supplement 15AP
2000-06-27Manufacturing (CMC) · Supplement 14AP
2000-05-18Manufacturing (CMC) · Supplement 12AP
2000-04-28Manufacturing (CMC) · Supplement 10AP
2000-03-28Manufacturing (CMC) · Supplement 13AP
1999-06-07Manufacturing (CMC) · Supplement 11AP
1998-12-29Manufacturing (CMC) · Supplement 4AP
1998-11-19Manufacturing (CMC) · Supplement 8AP
1998-10-22Manufacturing (CMC) · Supplement 5AP
1998-09-18Manufacturing (CMC) · Supplement 9AP
1998-05-07Manufacturing (CMC) · Supplement 6AP
1998-05-07Manufacturing (CMC) · Supplement 7AP
1997-09-03Manufacturing (CMC) · Supplement 3AP
1997-04-29Manufacturing (CMC) · Supplement 2AP
1996-06-06Manufacturing (CMC) · Supplement 1AP
1995-12-29OriginalAP
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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