Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018768
Company: CORDEN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VEPESID ETOPOSIDE 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
11/10/1983 ORIG-1 Approval Type 1 - New Molecular Entity 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
10/25/2000 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/05/2002 SUPPL-45 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/2002/018768_S045_VEPESIDE.pdf
02/02/2000 SUPPL-44 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/02/1999 SUPPL-41 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18768S041_VePesid.pdf
12/15/1998 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1995 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1995 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1995 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1993 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/20/1993 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

07/23/1993 SUPPL-30 Labeling

Label is not available on this site.

08/24/1993 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1995 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1991 SUPPL-26 Labeling

Label is not available on this site.

11/01/1991 SUPPL-25 Labeling

Label is not available on this site.

09/04/1990 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/10/1989 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1988 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1988 SUPPL-17 Labeling

Label is not available on this site.

05/20/1987 SUPPL-16 Labeling

Label is not available on this site.

04/28/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/19/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/22/1986 SUPPL-13 Labeling

Label is not available on this site.

10/29/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/30/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/26/1986 SUPPL-10 Labeling

Label is not available on this site.

11/06/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/04/1986 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

03/12/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1985 SUPPL-5 Labeling

Label is not available on this site.

03/06/1985 SUPPL-4 Labeling

Label is not available on this site.

03/06/1985 SUPPL-3 Labeling

Label is not available on this site.

03/06/1985 SUPPL-2 Labeling

Label is not available on this site.

08/21/1984 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
11/05/2002 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf

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