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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205323
Company: GLAND

Products on ANDA 205323

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
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205323

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/06/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205323Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/20/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205323

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	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	MYLAN LABS LTD
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	211007	NANJING KING-FRIEND
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	212061	NANJING KING-FRIEND
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	091682	SANDOZ
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

INJECTABLE;INJECTION; 1,000 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	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	214804	BE PHARMS
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017029	FRESENIUS KABI USA
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	205323	GLAND
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017037	HIKMA
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	090571	HOSPIRA INC
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	203851	MYLAN LABS LTD
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	211005	NANJING KING-FRIEND
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	211007	NANJING KING-FRIEND
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	090808	SAGENT PHARMS
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	091682	SANDOZ
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	202957	SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017029	FRESENIUS KABI USA
HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017029	FRESENIUS KABI USA
HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	090810	SAGENT PHARMS
HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	202732	SHENZHEN TECHDOW

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