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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207127
Company: SANALUZ

Products on ANDA 207127

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PYRIMETHAMINE	PYRIMETHAMINE	25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207127

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207127Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 207127

PYRIMETHAMINE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DARAPRIM	PYRIMETHAMINE	25MG	TABLET;ORAL	Prescription	Yes	AB	008578	TILDE SCIENCES
PYRIMETHAMINE	PYRIMETHAMINE	25MG	TABLET;ORAL	Prescription	No	AB	216983	AUROBINDO PHARMA LTD
PYRIMETHAMINE	PYRIMETHAMINE	25MG	TABLET;ORAL	Prescription	No	AB	207127	SANALUZ
PYRIMETHAMINE	PYRIMETHAMINE	25MG	TABLET;ORAL	Prescription	No	AB	215506	TEVA PHARMS

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