Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208137
Company: MYLAN LABS LTD

Products on ANDA 208137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208137

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208137

DOCETAXEL

INJECTABLE;INJECTION; 160MG/8ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	201195	ACCORD HLTHCARE
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203551	ACTAVIS
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209640	AMNEAL
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	207252	HENGRUI PHARMA
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	208137	MYLAN LABS LTD
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	205934	SHILPA
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210327	SHILPA
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	022534	SUN PHARM
TAXOTERE	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	020449	SANOFI AVENTIS US