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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022434
Company: CIPLA

Summary Review

Products on NDA 022434

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARGATROBAN IN SODIUM CHLORIDE	ARGATROBAN	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022434

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2011	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/2011/022434s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022434s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022434_argatroban_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022434Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2019	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022434s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022434Orig1s013ltr.pdf
06/18/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022434s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022434Orig1s011ltr.pdf
05/26/2016	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022434s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022434Orig1s010ltr.pdf
08/18/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/05/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/09/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022434s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022434Orig1s006ltr.pdf
01/16/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/10/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/20/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022434

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022434s013lbl.pdf
06/18/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022434s011lbl.pdf
05/26/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022434s010lbl.pdf
09/09/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022434s006lbl.pdf
06/29/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022434s000lbl.pdf

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