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FDA ANDA · ANDA074311

TRIFLURIDINE

Sponsor: SANDOZ

APPLICATION
ANDA074311
TYPE
ANDA
ORIGINAL APPROVAL
1995-10-06
LATEST ACTION
2002-12-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

TRIFLURIDINEPrescription
TRIFLURIDINE 1% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2002-12-19Labeling · Supplement 16AP
2002-10-01Manufacturing (CMC) · Supplement 15AP
2002-07-17Manufacturing (CMC) · Supplement 14AP
2001-04-30Manufacturing (CMC) · Supplement 12AP
2001-04-30Manufacturing (CMC) · Supplement 10AP
2001-04-30Labeling · Supplement 9AP
2001-04-30Manufacturing (CMC) · Supplement 13AP
2001-04-30Manufacturing (CMC) · Supplement 11AP
1999-02-19Manufacturing (CMC) · Supplement 6AP
1999-02-02Manufacturing (CMC) · Supplement 5AP
1997-04-16Manufacturing (CMC) · Supplement 4AP
1997-01-02Manufacturing (CMC) · Supplement 3AP
1996-07-30Manufacturing (CMC) · Supplement 2AP
1996-05-21Labeling · Supplement 1AP
1995-10-06OriginalAP
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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