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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203851
Company: MYLAN LABS LTD

Products on ANDA 203851

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203851

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203851Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2020	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203851

HEPARIN SODIUM

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

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; 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	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	MYLAN LABS LTD
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	211007	NANJING KING-FRIEND
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	201002	SANDOZ
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	Yes	AP	017029	FRESENIUS KABI USA
HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	089522	HOSPIRA
HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	212060	NANJING KING-FRIEND

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