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DIVALPROEX SODIUM

DIVALPROEX SODIUM

Approved
Approval ID

3de4f119-ceb6-4e73-9273-4be0451b0769

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 11, 2015

Manufacturers
FDA

DIRECT RX

DUNS: 079254320

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 Code61919-809
Application NumberANDA079163
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 11, 2015
Generic NameDIVALPROEX SODIUM

INGREDIENTS (24)

D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
DIVALPROEX SODIUMActive
Quantity: 250 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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DIVALPROEX SODIUM - FDA Drug Approval Details