Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209570
Company: CHEMO RESEARCH SL

Products on NDA 209570

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZNIDAZOLE	BENZNIDAZOLE	12.5MG	TABLET;ORAL	Prescription	None	Yes	No
BENZNIDAZOLE	BENZNIDAZOLE	100MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209570

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209570lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209570Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209570Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2021	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209570s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209570Orig1s002ltr.pdf
11/07/2019	SUPPL-1	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209570Orig1s001ltr.pdf

Labels for NDA 209570

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209570s002lbl.pdf
08/29/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209570lbl.pdf