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DIVALPROEX SODIUM

These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX sodium delayed-release tablets, for oral useInitial U.S. Approval: 1983

Approved
Approval ID

cd83f986-ec38-4e0e-aa03-3db5ad1629c6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 11, 2018

Manufacturers
FDA

Wockhardt USA LLC.

DUNS: 170508365

Products 1

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

DIVALPROEX SODIUM

PRODUCT DETAILS

NDC Product Code64679-975
Application NumberANDA077296
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 11, 2018
Generic NameDIVALPROEX SODIUM

INGREDIENTS (18)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
DIVALPROEX SODIUMActive
Quantity: 500 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT

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DIVALPROEX SODIUM - FDA Drug Approval Details