Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017398
Company: SANDOZ

Products on NDA 17398

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REGONOL	PYRIDOSTIGMINE BROMIDE	5MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Labels for NDA 017398

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2004	SUPPL-15	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf