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FDA ANDA · ANDA074449
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
Sponsor: BAUSCH AND LOMB
APPLICATION
ANDA074449
TYPE
ANDA
ORIGINAL APPROVAL
1995-12-29
LATEST ACTION
2001-11-27
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEPrescription
PREDNISOLONE SODIUM PHOSPHATE EQ 0.23% PHOSPHATE, SULFACETAMIDE SODIUM 10% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2001-11-27Manufacturing (CMC) · Supplement 11AP
2001-04-30Manufacturing (CMC) · Supplement 10AP
2001-03-07Manufacturing (CMC) · Supplement 9AP
2000-06-27Manufacturing (CMC) · Supplement 8AP
2000-05-18Manufacturing (CMC) · Supplement 6AP
2000-04-28Manufacturing (CMC) · Supplement 7AP
1999-06-07Manufacturing (CMC) · Supplement 5AP
1998-05-28Manufacturing (CMC) · Supplement 3AP
1998-04-30Manufacturing (CMC) · Supplement 1AP
1995-12-29OriginalAP
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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