Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206177
Company: DFB ONCOLOGY LTD

Products on ANDA 206177

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
DOCETAXEL	DOCETAXEL	200MG/10ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206177

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.