An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	211271	ALVOGEN
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

Top