Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207693
Company: ACCORD HLTHCARE

Products on ANDA 207693

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CABAZITAXEL	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207693

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207693

CABAZITAXEL

SOLUTION;INTRAVENOUS; 60MG/1.5ML (40MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CABAZITAXEL	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207693	ACCORD HLTHCARE
CABAZITAXEL	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207718	DR REDDYS
JEVTANA KIT	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	201023	SANOFI AVENTIS US