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

New Drug Application (NDA): 008578
Company: TILDE SCIENCES

Products on NDA 008578

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DARAPRIM	PYRIMETHAMINE	25MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008578

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/1953	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008578s020lbl.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s020lbl.pdf
03/16/2017	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008578Orig1s019ltr.pdf
11/18/2003	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08578slr016ltr.pdf
10/10/2002	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8578slr015ltr.pdf
04/08/1998	SUPPL-14	Labeling		Label is not available on this site.
03/25/1997	SUPPL-13	Labeling		Label is not available on this site.
04/08/1998	SUPPL-10	Labeling		Label is not available on this site.
10/17/1988	SUPPL-9	Labeling		Label is not available on this site.
02/20/1987	SUPPL-8	Labeling		Label is not available on this site.

Labels for NDA 008578

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s020lbl.pdf
03/16/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s019lbl.pdf
11/18/2003	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf
10/10/2002	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf
01/23/1953	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008578s020lbl.pdf

Therapeutic Equivalents for NDA 008578

DARAPRIM

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