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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217848
Company: GLAND PHARMA LTD

Products on ANDA 217848

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARGATROBAN	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217848

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217848

ARGATROBAN

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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