Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202626
Company: MYLAN INSTITUTIONAL

Products on ANDA 202626

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202626

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2023	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/01/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202626

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