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FDA Approval

Depakote

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 17, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Divalproex sodium(500 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Rebel Distributors Corp

Rebel Distributors Corp

118802834

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Depakote

Product Details

NDC Product Code
21695-163
Application Number
NDA021168
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
June 8, 2010
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: 644VL95AO6Class: ACTIBQuantity: 500 mg in 1 1
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT

Depakote

Product Details

NDC Product Code
21695-359
Application Number
NDA021168
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
June 8, 2010
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
Code: 644VL95AO6Class: ACTIBQuantity: 250 mg in 1 1
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