← FDA DRUG APPROVALS

FDA ANDA · ANDA064135

NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE

neomycin sulfate, polymyxin b sulfate and dexamethasone

Sponsor: BAUSCH AND LOMB INC

APPLICATION
ANDA064135
TYPE
ANDA
ORIGINAL APPROVAL
1995-09-13
LATEST ACTION
2023-07-21
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

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

Approval history

2023-07-21Labeling · Supplement 42 · standardAP
2020-02-07Labeling · Supplement 34 · standardAP
2002-02-05Manufacturing (CMC) · Supplement 13AP
2001-11-27Manufacturing (CMC) · Supplement 12AP
2001-03-07Manufacturing (CMC) · Supplement 11AP
2000-08-21Manufacturing (CMC) · Supplement 9AP
2000-06-27Manufacturing (CMC) · Supplement 10AP
2000-05-02Manufacturing (CMC) · Supplement 8AP
2000-04-28Manufacturing (CMC) · Supplement 7AP
1999-07-02Manufacturing (CMC) · Supplement 6AP
1998-11-19Manufacturing (CMC) · Supplement 5AP
1998-04-10Manufacturing (CMC) · Supplement 4AP
1998-02-11Manufacturing (CMC) · Supplement 3AP
1998-01-14Manufacturing (CMC) · Supplement 1AP
1997-08-19Manufacturing (CMC) · Supplement 2AP
1995-09-13OriginalAP
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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