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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020199
Company: ROCHE

Products on NDA 020199

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HIVID	ZALCITABINE	0.375MG	TABLET;ORAL	Discontinued	None	No	No
HIVID	ZALCITABINE	0.75MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020199

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/1992	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2002	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
09/12/2002	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s16lbl.pdf
08/14/2002	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20199slr015ltr.pdf
07/03/2002	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20199s014ltr.pdf
06/01/1999	SUPPL-13	Labeling		Label is not available on this site.
04/19/2000	SUPPL-12	Labeling		Label is not available on this site.
08/28/1998	SUPPL-11	Labeling		Label is not available on this site.
03/04/1998	SUPPL-10	Labeling		Label is not available on this site.
10/15/1997	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
10/04/1996	SUPPL-8	Labeling		Label is not available on this site.
06/26/1996	SUPPL-7	Efficacy-New Indication		Label is not available on this site.
03/04/1996	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
07/08/1994	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/07/1994	SUPPL-4	Labeling		Label is not available on this site.
08/05/1994	SUPPL-3	Efficacy-Accelerated Approval		Label is not available on this site.
10/07/1994	SUPPL-2	Labeling		Label is not available on this site.
04/13/1994	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020199

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2002	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s16lbl.pdf
08/14/2002	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s15lbl.pdf
07/03/2002	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s014lbl.pdf

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