Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211004
Company: EMERGE BIOSCIENCE

Products on ANDA 211004

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPARIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211004

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/2020	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
02/20/2026	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/25/2021	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/29/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211004

HEPARIN SODIUM

INJECTABLE;INJECTION; 20,000 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	20,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	211004	EMERGE BIOSCIENCE
HEPARIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017029	FRESENIUS KABI USA
HEPARIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	090809	SAGENT PHARMS
HEPARIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	203198	SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017029	FRESENIUS KABI USA