Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020215
Company: OMNIVIUM PHARMS

Products on NDA 20215

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONOKET	ISOSORBIDE MONONITRATE	20MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MONOKET	ISOSORBIDE MONONITRATE	10MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 020215

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/02/2014	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf