Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017425
Company: TEVA BRANDED PHARM

Products on NDA 17425

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROGLYCEM	DIAZOXIDE	50MG	CAPSULE;ORAL	Discontinued	None	No	No
PROGLYCEM	DIAZOXIDE	100MG	CAPSULE;ORAL	Discontinued	None	No	No

Labels for NDA 017425

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017425s017,017453s023lbl.pdf
09/18/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017425s016lbl.pdf