Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204120
Company: HOSPIRA

Products on ANDA 204120

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204120

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2016	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204120Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2019	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 204120

ARGATROBAN

INJECTABLE;INJECTION; 250MG/2.5ML (100MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	206698	AMNEAL PHARMS CO
ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	201811	FRESENIUS KABI USA
ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	203049	HIKMA PHARM CO LTD
ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204120	HOSPIRA
ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	202626	MYLAN INSTITUTIONAL
ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091665	PAR STERILE PRODUCTS