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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203049
Company: HIKMA PHARM CO LTD

Summary Review

Products on NDA 203049

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	Yes	Yes
ARGATROBAN	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203049

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/05/2012	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/2012/203049s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203049s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203049_argatroban_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203049Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203049s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203049Orig1s007ltr.pdf
05/26/2016	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203049Orig1s005ltr.pdf
09/30/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203049Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203049Orig1s004.pdf
10/16/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/13/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203049

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203049s007lbl.pdf
09/30/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s004lbl.pdf
05/26/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s005lbl.pdf
01/05/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203049s000lbl.pdf

Therapeutic Equivalents for NDA 203049

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

INJECTABLE;INJECTION; 50MG/50ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARGATROBAN	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	214235	CAPLIN
ARGATROBAN	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	217848	GLAND PHARMA LTD
ARGATROBAN	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	203049	HIKMA PHARM CO LTD

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