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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020828
Company: HOFFMANN LA ROCHE

Products on NDA 020828

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FORTOVASE	SAQUINAVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020828

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.

Labels for NDA 020828

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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