Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022267
Company: ABBVIE INC

• Other Important Information from FDA

• Summary Review

Products on NDA 022267

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEPAKOTE ER	DIVALPROEX SODIUM	250MG	TABLET, EXTENDED RELEASE; ORAL	Prescription	None	No	No
DEPAKOTE ER	DIVALPROEX SODIUM	500MG	TABLET, EXTENDED RELEASE; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022267

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2008	ORIG-1	Approval	Type 6 - New Indication (no longer used)	PRIORITY	Label (PDF) Review Summary Review (PDF)	See NDA 021168 for the most up-to-date labeling	https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022267lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022267_depakote_er_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022267s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2009	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022267s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022267s001ltr.pdf

Labels for NDA 022267

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2009	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022267s001lbl.pdf
03/24/2008	ORIG-1	Approval	Label (PDF)	See NDA 021168 for the most up-to-date labeling	https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022267lbl.pdf