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Drugs@FDA: FDA-Approved Drugs

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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	CEROVENE INC
PYRIMETHAMINE	PYRIMETHAMINE	25MG	TABLET;ORAL	Prescription	No	AB	215506	TEVA PHARMS

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