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Details for New Drug Application (NDA): 019680

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NDA 019680 describes DEPAKOTE, which is a drug marketed by Abbvie and Abbott and is included in four NDAs. It is available from four suppliers. There are six patents protecting this drug and two Paragraph IV challenges. Additional details are available on the DEPAKOTE profile page.

The generic ingredient in DEPAKOTE is divalproex sodium. There are seventeen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for NDA: 019680

divalproex sodium
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019680

Suppliers and Packaging for NDA: 019680

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
divalproex sodium
CAPSULE, DELAYED REL PELLETS;ORAL 019680 NDA AbbVie Inc. 0074-6114 0074-6114-11 10 BLISTER PACK in 1 CARTON (0074-6114-11) > 10 CAPSULE in 1 BLISTER PACK
divalproex sodium
CAPSULE, DELAYED REL PELLETS;ORAL 019680 NDA AbbVie Inc. 0074-6114 0074-6114-13 100 CAPSULE in 1 BOTTLE (0074-6114-13)

Summary for product number 001

Approval Date:Sep 12, 1989TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019680

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
divalproex sodium
CAPSULE, DELAYED REL PELLETS;ORAL019680-001Sep 12, 19894,988,731*PED► subscribe
divalproex sodium
CAPSULE, DELAYED REL PELLETS;ORAL019680-001Sep 12, 19895,212,326*PED► subscribe
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