APPLICATION
ANDA084305
TYPE
ANDA
ORIGINAL APPROVAL
1974-12-06
LATEST ACTION
2021-08-27
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
MYDRIACYL · ReferencePrescription
TROPICAMIDE 0.5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2021-08-27Labeling · Supplement 38 · standardAP
2003-10-31Labeling · Supplement 31AP
2002-12-23Manufacturing (CMC) · Supplement 30AP
2000-10-11Manufacturing (CMC) · Supplement 25AP
2000-05-16Manufacturing (CMC) · Supplement 22AP
2000-04-28Manufacturing (CMC) · Supplement 28AP
2000-04-07Manufacturing (CMC) · Supplement 29AP
1999-05-07Manufacturing (CMC) · Supplement 23AP
1999-04-21Manufacturing (CMC) · Supplement 26AP
1999-03-23Manufacturing (CMC) · Supplement 24AP
1999-03-04Manufacturing (CMC) · Supplement 21AP
1998-09-25Manufacturing (CMC) · Supplement 20AP
1997-02-07Labeling · Supplement 13AP
1997-01-22Manufacturing (CMC) · Supplement 19AP
1995-10-05Manufacturing (CMC) · Supplement 18AP
1995-08-04Manufacturing (CMC) · Supplement 17AP
1993-09-14Labeling · Supplement 16AP
1993-06-04Manufacturing (CMC) · Supplement 14AP
1993-06-04Manufacturing (CMC) · Supplement 12AP
1992-11-05Manufacturing (CMC) · Supplement 15AP
1989-04-26Manufacturing (CMC) · Supplement 11AP
1985-05-03Manufacturing (CMC) · Supplement 8AP
1984-01-13Manufacturing (CMC) · Supplement 7AP
1982-02-12Manufacturing (CMC) · Supplement 4AP
1974-12-06OriginalAP
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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