Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074983
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETOPOSIDE ETOPOSIDE 20MG/ML INJECTABLE;INJECTION Prescription AP No 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
09/30/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74983LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74983_Etoposide.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/05/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

10/11/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

06/23/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

ETOPOSIDE

INJECTABLE;INJECTION; 20MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ETOPOSIDE ETOPOSIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 074513 ACCORD HLTHCARE
ETOPOSIDE ETOPOSIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 074983 FRESENIUS KABI USA
ETOPOSIDE ETOPOSIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 074290 HIKMA
ETOPOSIDE ETOPOSIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 074529 TEVA PHARMS USA

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