← FDA DRUG APPROVALS
FDA ANDA · ANDA064063
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
neomycin sulfate, polymyxin b sulfate, and dexamethasone
Sponsor: BAUSCH AND LOMB INC
APPLICATION
ANDA064063
TYPE
ANDA
ORIGINAL APPROVAL
1994-07-25
LATEST ACTION
2020-02-07
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEPrescription
DEXAMETHASONE 0.1%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC
Approval history
2020-02-07Labeling · Supplement 42 · standardAP
2020-02-07Labeling · Supplement 41 · standardAP
2002-08-27Manufacturing (CMC) · Supplement 20AP
2002-08-27Manufacturing (CMC) · Supplement 19AP
2002-08-21Manufacturing (CMC) · Supplement 18AP
2002-02-05Manufacturing (CMC) · Supplement 17AP
2001-11-27Manufacturing (CMC) · Supplement 16AP
2001-03-07Manufacturing (CMC) · Supplement 15AP
2000-08-21Manufacturing (CMC) · Supplement 13AP
2000-06-27Manufacturing (CMC) · Supplement 14AP
2000-04-28Manufacturing (CMC) · Supplement 12AP
1999-06-07Manufacturing (CMC) · Supplement 11AP
1999-03-30Manufacturing (CMC) · Supplement 8AP
1999-02-11Manufacturing (CMC) · Supplement 10AP
1998-11-16Manufacturing (CMC) · Supplement 9AP
1998-10-22Manufacturing (CMC) · Supplement 6AP
1998-04-10Manufacturing (CMC) · Supplement 7AP
1997-07-23Manufacturing (CMC) · Supplement 5AP
1997-07-23Manufacturing (CMC) · Supplement 3AP
1997-07-23Labeling · Supplement 4AP
1996-10-04Manufacturing (CMC) · Supplement 2AP
1996-01-31Manufacturing (CMC) · Supplement 1AP
1994-07-25OriginalAP
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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