Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020782
Company: ABBOTT

• Other Important Information from FDA

Products on NDA 020782

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 020782

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review	See NDA 021168 for the most up-to-date labeling	https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20782_depakote_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20782,21168slr004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020782_s000_DepakoteTOC.cfm

Labels for NDA 020782

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2002	ORIG-1	Approval	Label (PDF)	See NDA 021168 for the most up-to-date labeling	https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20782_depakote_lbl.pdf