← FDA DRUG APPROVALS

FDA ANDA · ANDA062874

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

neomycin sulfate, polymyxin b sulfate and hydrocortisone

Sponsor: SANDOZ

APPLICATION
ANDA062874
TYPE
ANDA
ORIGINAL APPROVAL
1988-05-11
LATEST ACTION
2006-05-25
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/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 · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2006-05-25Labeling · Supplement 21AP
2004-10-21Labeling · Supplement 19AP
2003-02-04Labeling · Supplement 11AP
1999-02-19Manufacturing (CMC) · Supplement 9AP
1999-02-02Manufacturing (CMC) · Supplement 8AP
1996-04-16Manufacturing (CMC) · Supplement 6AP
1995-12-15Manufacturing (CMC) · Supplement 7AP
1994-06-16Labeling · Supplement 5AP
1993-12-21Manufacturing (CMC) · Supplement 4AP
1992-01-06Manufacturing (CMC) · Supplement 3AP
1989-01-31Manufacturing (CMC) · Supplement 2AP
1988-05-11OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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