Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020828
Company: HOFFMANN LA ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FORTOVASE SAQUINAVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
11/07/1997 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020828_fortovase_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/08/2005 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020828s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020828_S020_FORTOVASE.pdf
09/08/2005 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020828s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020828_S019_FORTOVASE.pdf
12/24/2003 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20828se2-015_fortovase_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20828se2-015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20828s015ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020828_S015_FORTOVASE.pdf
03/28/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/2002 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20828s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20828s010ltr.pdf
09/22/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/2000 SUPPL-8 Labeling

Label is not available on this site.

09/08/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1999 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020828_S006_FORTOVASE.pdf
12/04/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/05/1998 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/08/2005 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf
09/08/2005 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf
12/24/2003 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20828se2-015_fortovase_lbl.pdf
07/02/2002 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20828s10lbl.pdf

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