Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012157
Company: BAUSCH

Products on NDA 12157

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORFLEX	ORPHENADRINE CITRATE	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Labels for NDA 012157

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2007	SUPPL-28	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012157s028lbl.pdf