Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 009000
Company: NOVARTIS

Products on NDA 9000

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAFERGOT	CAFFEINE; ERGOTAMINE TARTRATE	100MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUPPOSITORY;RECTAL	Discontinued	None	Yes	No

Labels for NDA 009000

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/04/2002	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf
06/04/2002	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf