Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203852
Company: MYLAN LABS LTD

Products on ANDA 203852

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 203852

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/2017/203852Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203852

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	Yes	AP	017029	FRESENIUS KABI USA
HEPARIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	203852	MYLAN LABS LTD
HEPARIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	No	AP	211004	NANJING KING-FRIEND
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