Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205570
Company: GLAND

Products on ANDA 205570

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARGATROBAN IN SODIUM CHLORIDE	ARGATROBAN	125MG/125ML (1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205570

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205570Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 205570

ARGATROBAN IN SODIUM CHLORIDE

INJECTABLE;INTRAVENOUS; 125MG/125ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARGATROBAN IN SODIUM CHLORIDE	ARGATROBAN	125MG/125ML (1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205570	GLAND
ARGATROBAN IN SODIUM CHLORIDE	ARGATROBAN	125MG/125ML (1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	022485	PLANO PHARMS