APPLICATION
NDA017431
TYPE
NDA
ORIGINAL APPROVAL
1974-07-29
LATEST ACTION
1999-01-20
ROUTE
OPHTHALMIC
DOSAGE FORM
INSERT, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
OCUSERT PILO-20Discontinued
PILOCARPINE 5MG · INSERT, EXTENDED RELEASE · OPHTHALMIC
Approval history
1999-01-20Manufacturing (CMC) · Supplement 30 · priorityAP
1993-08-13Manufacturing (CMC) · Supplement 28 · priorityAP
1992-12-11Manufacturing (CMC) · Supplement 27 · priorityAP
1991-12-02Labeling · Supplement 26 · priorityAP
1990-10-18Manufacturing (CMC) · Supplement 25 · priorityAP
1990-10-18Manufacturing (CMC) · Supplement 23 · priorityAP
1990-08-24Manufacturing (CMC) · Supplement 22 · priorityAP
1989-11-09Manufacturing (CMC) · Supplement 21 · priorityAP
1988-01-11Manufacturing (CMC) · Supplement 20 · priorityAP
1987-04-21Manufacturing (CMC) · Supplement 19 · priorityAP
1987-04-08Labeling · Supplement 14 · priorityAP
1983-02-04Manufacturing (CMC) · Supplement 17 · priorityAP
1982-03-24Manufacturing (CMC) · Supplement 15 · priorityAP
1981-02-17Labeling · Supplement 11 · priorityAP
1980-11-19Manufacturing (CMC) · Supplement 12 · priorityAP
1979-03-29Labeling · Supplement 10 · priorityAP
1979-03-14Labeling · Supplement 9 · priorityAP
1978-12-07Labeling · Supplement 7 · priorityAP
1978-11-30Manufacturing (CMC) · Supplement 8 · priorityAP
1977-08-11Manufacturing (CMC) · Supplement 6 · priorityAP
1975-04-01Manufacturing (CMC) · Supplement 3 · priorityAP
1975-02-21Manufacturing (CMC) · Supplement 2 · priorityAP
1974-07-29Type 3 - New Dosage Form · Original · priorityAP
1974-07-29UNKNOWN · Supplement 1 · 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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