APPLICATION
NDA012302
TYPE
NDA
ORIGINAL APPROVAL
1967-04-14
LATEST ACTION
1989-04-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CHOLOXINDiscontinued
DEXTROTHYROXINE SODIUM 1MG · TABLET · ORAL
CHOLOXINDiscontinued
DEXTROTHYROXINE SODIUM 6MG · TABLET · ORAL
CHOLOXINDiscontinued
DEXTROTHYROXINE SODIUM 4MG · TABLET · ORAL
CHOLOXINDiscontinued
DEXTROTHYROXINE SODIUM 2MG · TABLET · ORAL
Approval history
1989-04-20Labeling · Supplement 45 · priorityAP
1988-10-03Labeling · Supplement 43 · priorityAP
1984-05-02Manufacturing (CMC) · Supplement 44 · priorityAP
1982-04-13Manufacturing (CMC) · Supplement 42 · priorityAP
1980-09-17Labeling · Supplement 39 · priorityAP
1978-10-12Labeling · Supplement 32 · priorityAP
1975-10-03Manufacturing (CMC) · Supplement 28 · priorityAP
1967-04-14Type 2 - New Active Ingredient · 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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