Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019557
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VEPESID ETOPOSIDE 50MG CAPSULE;ORAL Discontinued None Yes No
VEPESID ETOPOSIDE 100MG 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
12/30/1986 ORIG-1 Approval Type 3 - New Dosage Form 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
11/05/2002 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18768slr045,19557slr028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019557_S028_VEPESIDE.pdf
11/21/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/2000 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/02/1999 SUPPL-23 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19557S023_VePesid.pdf
01/19/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/15/1998 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1993 SUPPL-15 Labeling

Label is not available on this site.

03/02/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/17/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1991 SUPPL-10 Labeling

Label is not available on this site.

11/01/1991 SUPPL-9 Labeling

Label is not available on this site.

07/14/1989 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1988 SUPPL-6 Labeling

Label is not available on this site.

08/24/1987 SUPPL-5 Labeling

Label is not available on this site.

08/24/1987 SUPPL-4 Labeling

Label is not available on this site.

05/20/1987 SUPPL-3 Labeling

Label is not available on this site.

03/26/1987 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/05/2002 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf

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