APPLICATION
NDA010598
TYPE
NDA
ORIGINAL APPROVAL
1956-07-30
LATEST ACTION
1982-12-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BENDECTINDiscontinued
DOXYLAMINE SUCCINATE 10MG, PYRIDOXINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
Approval history
1982-12-09Manufacturing (CMC) · Supplement 14 · standardAP
1982-09-07Labeling · Supplement 13AP
1982-06-16Manufacturing (CMC) · Supplement 12 · standardAP
1981-10-22Labeling · Supplement 11AP
1981-10-22Labeling · Supplement 10AP
1981-01-09Labeling · Supplement 9AP
1979-11-06Manufacturing (CMC) · Supplement 8 · standardAP
1979-07-25Manufacturing (CMC) · Supplement 7 · standardAP
1978-11-01Manufacturing (CMC) · Supplement 6 · standardAP
1978-08-01Labeling · Supplement 5AP
1976-11-09Labeling · Supplement 3AP
1976-11-09Efficacy · Supplement 2AP
1956-07-30Type 4 - New Combination · 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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