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): 018557
Company: ROCHE

Products on NDA 018557

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FANSIDAR	PYRIMETHAMINE; SULFADOXINE	25MG;500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018557

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/1981	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2003	SUPPL-16	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18557slr016ltr.pdf
02/26/2004	SUPPL-15	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18557slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018557_S015_Fandsidar_APPROVAL PACKAGE.pdf
08/14/1998	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/09/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/03/1987	SUPPL-12	Labeling		Label is not available on this site.
04/30/1987	SUPPL-11	Labeling		Label is not available on this site.
07/24/1985	SUPPL-10	Labeling		Label is not available on this site.
07/24/1985	SUPPL-9	Labeling		Label is not available on this site.
07/24/1985	SUPPL-8	Labeling		Label is not available on this site.
07/24/1985	SUPPL-7	Labeling		Label is not available on this site.
10/26/1983	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/1983	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/21/1983	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/21/1983	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018557

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2004	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.pdf

Top