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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213768
Company: GUANGDONG SUNHO

Products on ANDA 213768

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213768

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213768

DOCETAXEL

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	201195	ACCORD HLTHCARE
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203551	ACTAVIS
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209640	AMNEAL
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204193	DR REDDYS
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213768	GUANGDONG SUNHO
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	207252	HENGRUI PHARMA
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	216677	HERITAGE
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204490	HIKMA
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	205934	SHILPA
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210327	SHILPA

INJECTABLE;INJECTION; 80MG/4ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	201195	ACCORD HLTHCARE
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203551	ACTAVIS
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209640	AMNEAL
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204193	DR REDDYS
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213768	GUANGDONG SUNHO
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	207252	HENGRUI PHARMA
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	216677	HERITAGE
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204490	HIKMA
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	205934	SHILPA
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210327	SHILPA

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