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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219897
Company: NOVITIUM PHARMA

Products on ANDA 219897

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIMOZIDE	PIMOZIDE	1MG	TABLET;ORAL	Prescription	AB	No	No
PIMOZIDE	PIMOZIDE	2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219897

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/13/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219897

PIMOZIDE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PIMOZIDE	PIMOZIDE	1MG	TABLET;ORAL	Prescription	No	AB	219897	NOVITIUM PHARMA
PIMOZIDE	PIMOZIDE	1MG	TABLET;ORAL	Prescription	No	AB	204521	PH HEALTH

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PIMOZIDE	PIMOZIDE	2MG	TABLET;ORAL	Prescription	No	AB	219897	NOVITIUM PHARMA
PIMOZIDE	PIMOZIDE	2MG	TABLET;ORAL	Prescription	No	AB	204521	PH HEALTH

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