Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018557
Company: ROCHE
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
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.

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

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