APPLICATION
NDA016211
TYPE
NDA
ORIGINAL APPROVAL
1973-10-09
LATEST ACTION
1996-10-16
ROUTE
OPHTHALMIC
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
MIOCHOL · ReferenceDiscontinued
ACETYLCHOLINE CHLORIDE 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · OPHTHALMIC
Approval history
1996-10-16Manufacturing (CMC) · Supplement 24 · standardAP
1996-07-30Labeling · Supplement 23 · standardAP
1990-10-31Labeling · Supplement 19 · standardAP
1988-10-17Labeling · Supplement 17 · standardAP
1987-12-04Manufacturing (CMC) · Supplement 20 · standardAP
1987-03-30Labeling · Supplement 13 · standardAP
1986-10-24Labeling · Supplement 12 · standardAP
1985-09-04Manufacturing (CMC) · Supplement 18 · standardAP
1985-04-29Manufacturing (CMC) · Supplement 15 · standardAP
1984-05-08Labeling · Supplement 16 · standardAP
1983-12-06Manufacturing (CMC) · Supplement 14 · standardAP
1981-07-20Manufacturing (CMC) · Supplement 11 · standardAP
1981-06-25Manufacturing (CMC) · Supplement 10 · standardAP
1979-08-16Manufacturing (CMC) · Supplement 9 · standardAP
1977-02-10Manufacturing (CMC) · Supplement 8 · standardAP
1973-10-09Type 1 - New Molecular Entity · 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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