← FDA DRUG APPROVALS

FDA ANDA · ANDA064068

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

neomycin sulfate and polymyxin b sulfate, bacitracin zinc and hydrocortisone

Sponsor: BAUSCH AND LOMB INC

APPLICATION
ANDA064068
TYPE
ANDA
ORIGINAL APPROVAL
1995-10-30
LATEST ACTION
2002-08-06
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEPrescription
BACITRACIN ZINC 400 UNITS/GM, HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC

Approval history

2002-08-06Manufacturing (CMC) · Supplement 17AP
2002-07-18Manufacturing (CMC) · Supplement 18AP
2002-07-18Manufacturing (CMC) · Supplement 16AP
2002-02-05Manufacturing (CMC) · Supplement 15AP
2001-11-27Manufacturing (CMC) · Supplement 14AP
2001-03-07Manufacturing (CMC) · Supplement 13AP
2000-08-24Manufacturing (CMC) · Supplement 10AP
2000-06-27Manufacturing (CMC) · Supplement 12AP
2000-04-28Manufacturing (CMC) · Supplement 9AP
2000-04-21Manufacturing (CMC) · Supplement 11AP
1999-06-07Manufacturing (CMC) · Supplement 8AP
1999-03-30Manufacturing (CMC) · Supplement 5AP
1999-03-05Manufacturing (CMC) · Supplement 7AP
1998-11-23Manufacturing (CMC) · Supplement 6AP
1998-10-22Manufacturing (CMC) · Supplement 3AP
1998-05-11Manufacturing (CMC) · Supplement 4AP
1997-09-03Manufacturing (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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