← FDA DRUG APPROVALS

FDA ANDA · ANDA062341

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

neomycin sulfate, polymyxin b sulfate and dexamethasone

Sponsor: SANDOZ

APPLICATION
ANDA062341
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-22
LATEST ACTION
2008-09-15
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

MAXITROLPrescription
DEXAMETHASONE 0.1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2008-09-15Labeling · Supplement 31AP
2002-12-23Manufacturing (CMC) · Supplement 21AP
2001-01-23Manufacturing (CMC) · Supplement 20AP
2000-04-28Manufacturing (CMC) · Supplement 19AP
1999-05-07Manufacturing (CMC) · Supplement 16AP
1999-04-21Manufacturing (CMC) · Supplement 18AP
1999-03-23Manufacturing (CMC) · Supplement 17AP
1999-03-04Manufacturing (CMC) · Supplement 15AP
1996-04-18Manufacturing (CMC) · Supplement 12AP
1996-04-18Manufacturing (CMC) · Supplement 11AP
1996-04-01Manufacturing (CMC) · Supplement 13AP
1996-03-12Labeling · Supplement 10AP
1995-12-06Manufacturing (CMC) · Supplement 7AP
1995-12-06Manufacturing (CMC) · Supplement 6AP
1995-10-05Manufacturing (CMC) · Supplement 9AP
1995-08-04Manufacturing (CMC) · Supplement 8AP
1990-12-06Manufacturing (CMC) · Supplement 4AP
1990-12-05Manufacturing (CMC) · Supplement 3AP
1984-05-22OriginalAP
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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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