Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074983
Company: FRESENIUS KABI USA

Products on ANDA 074983

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETOPOSIDE	ETOPOSIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074983

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.

Therapeutic Equivalents for ANDA 074983

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	MEITHEAL