APPLICATION
NDA018796
TYPE
NDA
ORIGINAL APPROVAL
1984-10-01
LATEST ACTION
2008-04-17
ROUTE
OPHTHALMIC
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued
Products
PILOPINE HSDiscontinued
PILOCARPINE HYDROCHLORIDE 4% · GEL · OPHTHALMIC
Approval history
1999-12-10Manufacturing (CMC) · Supplement 12 · standardAP
1997-10-16Manufacturing (CMC) · Supplement 11 · standardAP
1996-11-29Manufacturing (CMC) · Supplement 9 · standardAP
1993-10-27Manufacturing (CMC) · Supplement 8 · standardAP
1993-04-13Manufacturing (CMC) · Supplement 7 · standardAP
1991-12-31Manufacturing (CMC) · Supplement 6 · standardAP
1991-12-31Labeling · Supplement 5AP
1988-12-13Manufacturing (CMC) · Supplement 4 · standardAP
1988-10-17Labeling · Supplement 1AP
1987-06-24Manufacturing (CMC) · Supplement 3 · standardAP
1984-10-01Type 3 - New Dosage Form · Original · standardAP
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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