Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074513
Company: ACCORD HLTHCARE

Products on ANDA 074513

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/1996	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75513ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2011	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 074513

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