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divalproex

Generic: DIVALPROEX SODIUM·Brand: DEPAKOTE, DEPAKOTE CP, DEPAKOTE ER, DIVALPROEX SODIUM

divalproex: developed by 2 companies · 1 clinical trial tracked · 4 FDA decisions.

divalproex evidence translation

What we can confirm

4 FDA records · 1 tracked trial

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about divalproex, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

Development Pipeline (2)
CompanyPhase
DR REDDYS LABORATORIES LTD (RDY)Approved
Teva Pharmaceutical Industries Limited (TEVA)Approved
Clinical Trials (1)

Phase 1/2 Study of Neratinib and Divalproex Sodium (Valproate) in Advanced Solid Tumors, With an Expansion Cohort in Ras-Mutated Cancers

NCT03919292·Phase 1/Phase 2
Suspended

Primary endpoint: Determination of Recommended Phase 2 Dose (RP2D)

Interventionalopen83 targetStarted 2019-05Completion 2031-011 site · United StatesVirginia Commonwealth University
FDA Decisions4 records
Approval1 INDICATIONS AND USAGE Divalproex sodium extended-release tablet is indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2) Prophylaxis of migraine headaches (1.3) 1.1 Mania Divalproex sodium extended-release tablet is a va(RDY)FDA ↗
ANDA090161OralTablet, Extended Release
Approval1 INDICATIONS AND USAGE Divalproex sodium delayed-release capsule is an anti-epileptic drug indicated for : Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1) 1.1 Epilepsy Divalproex sodium delayed-release capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years w(RDY)FDA ↗
ANDA078979OralCapsule, Delayed Rel Pellets
Approval1 INDICATIONS AND USAGE Divalproex sodium extended-release tablets are indicated for: • Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ( 1.1 ) • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2 ) • Prophylaxis of migraine headaches ( 1.3 ) 1.1 Mania Divalproex sodium extended-release (TEVA)FDA ↗
ANDA076941OralTablet, Delayed Release
Approval1 INDICATIONS AND USAGE Divalproex sodium delayed-release tablet is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder (1.1) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2) Prophylaxis of migraine headaches (1.3) 1.1 Mania Divalproex sodium delayed-release tablet is a valproate and is indicated for t(RDY)FDA ↗
ANDA078755OralTablet, Delayed Release

Frequently asked questions

Who is developing divalproex?

divalproex is being developed by DR REDDYS LABORATORIES LTD, Teva Pharmaceutical Industries Limited.

How many clinical trials involve divalproex?

BioSniper tracks 1 clinical trial involving divalproex.

What is divalproex's latest FDA decision?

The most recent tracked FDA decision for divalproex is Approval for 1 INDICATIONS AND USAGE Divalproex sodium extended-release tablet is indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2) Prophylaxis of migraine headaches (1.3) 1.1 Mania Divalproex sodium extended-release tablet is a va, dated March 15, 2012.