Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206552
Company: FRESENIUS KABI USA

Products on ANDA 206552

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206552

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206552Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206552Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 206552

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206552Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 206552

HEPARIN SODIUM

INJECTABLE;INJECTION; 5,000 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	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	211007	EMERGE BIOSCIENCE
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	212061	EMERGE BIOSCIENCE
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017651	FRESENIUS KABI USA
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	206552	FRESENIUS KABI USA
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	205323	GLAND
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017037	HIKMA
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	090571	HOSPIRA INC
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	203851	PHARMOBEDIENT
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	091682	PLANO PHARMS
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	090808	SAGENT PHARMS
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	202733	SHENZHEN TECHDOW
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	202957	SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017029	FRESENIUS KABI USA