Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204476
Company: UNICHEM

Products on ANDA 204476

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204476

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2014	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
08/18/2025	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/27/2023	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
02/27/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204476

PRIMAQUINE PHOSPHATE

TABLET;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PRIMAQUINE	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET;ORAL	Prescription	Yes	AB	008316	SANOFI AVENTIS US
PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	206043	NOVAST LABS
PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	204476	UNICHEM