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FDA ANDA · ANDA076570
TRIMETHOBENZAMIDE HYDROCHLORIDE
Sponsor: SUN PHARM INDUSTRIES
APPLICATION
ANDA076570
TYPE
ANDA
ORIGINAL APPROVAL
2003-08-28
LATEST ACTION
2020-04-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TRIMETHOBENZAMIDE HYDROCHLORIDEDiscontinued
TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG · CAPSULE · ORAL
Approval history
2020-04-22Labeling · Supplement 18 · standardAP
2010-10-29Labeling · Supplement 11AP
2008-06-18Labeling · Supplement 9AP
2003-08-28OriginalAP
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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