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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219606
Company: BPI LABS

Products on ANDA 219606

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219606

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219606

TRIMETHOBENZAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIGAN	TRIMETHOBENZAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017530	PH HEALTH
TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	219606	BPI LABS

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