APPLICATION
ANDA076546
TYPE
ANDA
ORIGINAL APPROVAL
2003-08-20
LATEST ACTION
2020-04-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TRIMETHOBENZAMIDE HYDROCHLORIDEPrescription
TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG · CAPSULE · ORAL
Approval history
2020-04-22Labeling · Supplement 10 · standardAP
2015-06-09Labeling · Supplement 7AP
2004-02-13Labeling · Supplement 1AP
2003-08-20OriginalAP
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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