Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020199
Company: ROCHE
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
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.

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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