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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022485
Company: SANDOZ

Summary Review

Products on NDA 022485

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	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022485

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022485lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000(1)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485_argatroban_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2019	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022485s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022485Orig1s013ltr.pdf
07/03/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022485s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022485Orig1s011ltr.pdf
05/26/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022485s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022485Orig1s009ltr.pdf
12/01/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/11/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022485

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022485s013lbl.pdf
07/03/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022485s011lbl.pdf
05/26/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022485s009lbl.pdf
05/09/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022485lbl.pdf

Therapeutic Equivalents for NDA 022485

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 PHARMA LTD
ARGATROBAN IN SODIUM CHLORIDE	ARGATROBAN	125MG/125ML (1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	022485	SANDOZ

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