APPLICATION
NDA010021
TYPE
NDA
ORIGINAL APPROVAL
1961-05-10
LATEST ACTION
1998-05-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PLACIDYLDiscontinued
ETHCHLORVYNOL 100MG · CAPSULE · ORAL
PLACIDYLDiscontinued
ETHCHLORVYNOL 750MG · CAPSULE · ORAL
PLACIDYLDiscontinued
ETHCHLORVYNOL 500MG · CAPSULE · ORAL
PLACIDYLDiscontinued
ETHCHLORVYNOL 200MG · CAPSULE · ORAL
Approval history
1998-05-08Manufacturing (CMC) · Supplement 44 · standardAP
1995-10-19Manufacturing (CMC) · Supplement 43 · standardAP
1989-05-04Manufacturing (CMC) · Supplement 42 · standardAP
1987-12-03Manufacturing (CMC) · Supplement 41 · standardAP
1986-12-05Manufacturing (CMC) · Supplement 40 · standardAP
1986-03-12Manufacturing (CMC) · Supplement 35 · standardAP
1983-12-08Labeling · Supplement 36 · standardAP
1982-10-01Manufacturing (CMC) · Supplement 39 · standardAP
1982-03-22Labeling · Supplement 38 · standardAP
1981-11-19Manufacturing (CMC) · Supplement 37 · standardAP
1981-03-06Manufacturing (CMC) · Supplement 34 · standardAP
1979-12-07Labeling · Supplement 33 · standardAP
1976-05-07Manufacturing (CMC) · Supplement 29 · standardAP
1976-03-10Manufacturing (CMC) · Supplement 28 · standardAP
1961-05-10Type 5 - New Formulation or New Manufacturer · Original · standard — Other Important Information from FDA ↗AP
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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