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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201811
Company: FRESENIUS KABI USA

Summary Review

Products on NDA 201811

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 NDA 201811

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201811s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201811Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2018	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201811s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201811Orig1s006ltr.pdf
05/25/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201811s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201811Orig1s003ltr.pdf
12/11/2015	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 201811

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201811s006lbl.pdf
05/25/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201811s003lbl.pdf
03/23/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201811s000lbl.pdf

Therapeutic Equivalents for NDA 201811

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	091665	ENDO OPERATIONS
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

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