APPLICATION
ANDA086577
TYPE
ANDA
ORIGINAL APPROVAL
1982-10-19
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRIMETHOBENZAMIDE HYDROCHLORIDEDiscontinued
TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 12AP
1999-02-02Manufacturing (CMC) · Supplement 11AP
1996-12-04Manufacturing (CMC) · Supplement 9AP
1992-08-06Labeling · Supplement 8AP
1991-09-30Labeling · Supplement 7AP
1991-02-23Manufacturing (CMC) · Supplement 6AP
1991-02-23Manufacturing (CMC) · Supplement 4AP
1991-02-23Manufacturing (CMC) · Supplement 5AP
1986-04-30Manufacturing (CMC) · Supplement 2AP
1984-04-02Manufacturing (CMC) · Supplement 1AP
1982-10-19OriginalAP
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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