APPLICATION
NDA018239
TYPE
NDA
ORIGINAL APPROVAL
1980-05-02
LATEST ACTION
2003-03-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
PROPINEDiscontinued
DIPIVEFRIN HYDROCHLORIDE 0.1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2003-03-19Labeling · Supplement 31 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 29 · priorityAP
2001-12-04Manufacturing (CMC) · Supplement 27 · priorityAP
2001-04-12Manufacturing (CMC) · Supplement 26 · priorityAP
2000-10-02Manufacturing (CMC) · Supplement 24 · priorityAP
2000-03-07Manufacturing (CMC) · Supplement 23 · priorityAP
1998-10-22Manufacturing (CMC) · Supplement 22 · priorityAP
1997-04-18Manufacturing (CMC) · Supplement 21 · priorityAP
1995-08-03Manufacturing (CMC) · Supplement 20 · priorityAP
1994-01-13Manufacturing (CMC) · Supplement 19 · priorityAP
1989-10-23Manufacturing (CMC) · Supplement 16 · priorityAP
1989-10-23Labeling · Supplement 17AP
1989-10-11Manufacturing (CMC) · Supplement 18 · priorityAP
1988-02-09Labeling · Supplement 14AP
1987-08-12Manufacturing (CMC) · Supplement 5 · priorityAP
1987-05-14Manufacturing (CMC) · Supplement 13 · priorityAP
1987-04-09Labeling · Supplement 6AP
1986-10-16Manufacturing (CMC) · Supplement 12 · priorityAP
1983-12-02Labeling · Supplement 9AP
1982-09-02Manufacturing (CMC) · Supplement 2 · priorityAP
1982-09-02Manufacturing (CMC) · Supplement 3 · priorityAP
1982-08-13Manufacturing (CMC) · Supplement 7 · priorityAP
1980-10-22Manufacturing (CMC) · Supplement 4 · priorityAP
1980-06-05Labeling · Supplement 1AP
1980-05-02Type 3 - New Dosage Form · Original · priorityAP
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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