Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076546
Company: LUPIN

Products on ANDA 076546

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076546

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/09/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
02/13/2004	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076546

TRIMETHOBENZAMIDE HYDROCHLORIDE

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE;ORAL	Prescription	No	AB	205950	AVET LIFESCIENCES
TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE;ORAL	Prescription	No	AB	076546	LUPIN
TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE;ORAL	Prescription	No	AB	076570	SUN PHARM INDUSTRIES