Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016931
Company: PHARMACIA AND UPJOHN

Products on NDA 16931

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
R-GENE 10	ARGININE HYDROCHLORIDE	10GM/100ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Labels for NDA 016931

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2010	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016931s031lbl.pdf
08/13/2003	SUPPL-28	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16931slr028_r-gene_lbl.pdf