Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212700
Company: HENGRUI PHARMA

Products on ANDA 212700

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212700

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/08/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2025	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212700

PACLITAXEL

POWDER;INTRAVENOUS; 100MG/VIAL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABRAXANE	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AB	021660	BRISTOL-MYERS
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AB	211875	AM REGENT
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AB	209657	CIPLA
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AB	212700	HENGRUI PHARMA
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AB	217877	MYLAN
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AB	216355	SHUANGCHENG
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AB	216338	TEVA PHARMS INC