Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019661
Company: CHEPLAPHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTOVENE GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/23/1989 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
08/06/2018 SUPPL-37 Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019661s037lbl.pdf
07/03/2017 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019661s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019661Orig1s036ltr.pdf
03/17/2016 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/08/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/31/2006 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019661s030ltr.pdf
10/25/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/2002 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/21/2002 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/2000 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/2000 SUPPL-25 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/01/2000 SUPPL-24 Labeling

Label is not available on this site.

08/27/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/14/1997 SUPPL-22 Labeling

Label is not available on this site.

05/23/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/29/1996 SUPPL-20 Labeling

Label is not available on this site.

05/08/1996 SUPPL-19 Labeling

Label is not available on this site.

08/08/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1995 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/20/1995 SUPPL-15 Labeling

Label is not available on this site.

09/13/1994 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1994 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1992 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1992 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1992 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

06/19/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/17/1992 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1990 SUPPL-4 Labeling

Label is not available on this site.

02/09/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/06/2018 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019661s037lbl.pdf
08/06/2018 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019661s037lbl.pdf
07/03/2017 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019661s036lbl.pdf
01/31/2006 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf

CYTOVENE

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOVENE GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 019661 CHEPLAPHARM
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 212001 CUSTOPHARM INC
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090658 FRESENIUS KABI USA
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204204 HAINAN POLY PHARM
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204560 MYLAN LABS LTD
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204950 PAR STERILE PRODUCTS
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207645 PHARMASCIENCE INC

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