APPLICATION
NDA012329
TYPE
NDA
ORIGINAL APPROVAL
1960-07-05
LATEST ACTION
1986-10-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISMELINDiscontinued
GUANETHIDINE MONOSULFATE EQ 10MG SULFATE · TABLET · ORAL
ISMELINDiscontinued
GUANETHIDINE MONOSULFATE EQ 25MG SULFATE · TABLET · ORAL
Approval history
1986-10-22Labeling · Supplement 54AP
1986-05-05Labeling · Supplement 52AP
1986-05-05Labeling · Supplement 50AP
1986-05-05Labeling · Supplement 53AP
1985-03-19Manufacturing (CMC) · Supplement 51 · priorityAP
1981-02-02Manufacturing (CMC) · Supplement 49 · priorityAP
1980-12-12Labeling · Supplement 48AP
1980-05-08Labeling · Supplement 47AP
1980-01-24Manufacturing (CMC) · Supplement 46 · priorityAP
1980-01-17Manufacturing (CMC) · Supplement 45 · priorityAP
1979-06-25Manufacturing (CMC) · Supplement 44 · priorityAP
1979-06-25Manufacturing (CMC) · Supplement 42 · priorityAP
1979-06-25Manufacturing (CMC) · Supplement 43 · priorityAP
1979-02-12Manufacturing (CMC) · Supplement 39 · priorityAP
1979-01-31Manufacturing (CMC) · Supplement 40 · priorityAP
1979-01-08Labeling · Supplement 41AP
1977-06-29Manufacturing (CMC) · Supplement 38 · priorityAP
1977-04-12Manufacturing (CMC) · Supplement 37 · priorityAP
1976-12-29Manufacturing (CMC) · Supplement 35 · priorityAP
1976-12-02Manufacturing (CMC) · Supplement 36 · priorityAP
1976-03-19Manufacturing (CMC) · Supplement 33 · priorityAP
1976-02-03Manufacturing (CMC) · Supplement 34 · priorityAP
1975-09-26Labeling · Supplement 25AP
1975-09-26Labeling · Supplement 22AP
1975-07-02Manufacturing (CMC) · Supplement 32 · priorityAP
1975-05-15REMS · Supplement 23 · priorityAP
1975-05-15REMS · Supplement 26 · priorityAP
1975-03-31Manufacturing (CMC) · Supplement 28 · priorityAP
1975-03-31Manufacturing (CMC) · Supplement 30 · priorityAP
1975-03-31Manufacturing (CMC) · Supplement 29 · priorityAP
1960-07-05Type 1 - New Molecular Entity · Original · priorityAP
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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