Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016199
Company: ANI PHARMS

Products on NDA 16199

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORTENEMA	HYDROCORTISONE	100MG/60ML	ENEMA;RECTAL	Prescription	AB	Yes	Yes

Labels for NDA 016199

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2008	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016199s035lbl.pdf