Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212060
Company: EMERGE BIOSCIENCE

Products on ANDA 212060

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212060

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212060

HEPARIN SODIUM PRESERVATIVE FREE

INJECTABLE;INJECTION; 10,000 UNITS/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	214839	BE PHARMS
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	211007	EMERGE BIOSCIENCE
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017029	FRESENIUS KABI USA
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017037	HIKMA
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	090571	HOSPIRA INC
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	203851	PHARMOBEDIENT
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	201002	PLANO PHARMS
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	090808	SAGENT PHARMS
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	203198	SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017029	FRESENIUS KABI USA
HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	212060	EMERGE BIOSCIENCE
HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017029	FRESENIUS KABI USA
HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	089522	HOSPIRA