Divalproex Sodium (Divalproex Sodium)

Trade Name : Divalproex Sodium

Amneal Pharmaceuticals LLC

TABLET, EXTENDED RELEASE

Strength 500 mg/1

DIVALPROEX SODIUM Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Divalproex Sodium (Divalproex Sodium) which is also known as Divalproex Sodium and Manufactured by Amneal Pharmaceuticals LLC. It is available in strength of 500 mg/1 per ml. Read more

Divalproex Sodium (Divalproex Sodium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Hepatotoxicity
Arrayn- Array
Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When divalproex sodium extended-release is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.
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Fetal Risk
Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores and neurodevelopmental disorders following exposure.
Valproate is therefore contraindicated for prophylaxis of migraine headaches in pregnant women and in women of childbearing potential who are not using effective contraception u00a0. Valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.
Valproate should not be administered to a woman of childbearing potential unless n- other medications have failed to provide adequate symptom control or are otherwise unacceptable. In such situations, effective contraception should be used n- Array
A Medication Guide describing the risks of valproate is available for patients .
Pancreatitis
WARNING: LIFE THREATENING ADVERSE REACTIONS
See full prescribing information for complete boxed warning.

Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafteru00a0 u00a0
Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQu00a0u00a0u00a0n
Pancreatitis, including fatal hemorrhagic casesu00a0n

Divalproex sodium extended-release tablets are indicated for:

Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic featuresu00a0n
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 seizuresu00a0u00a0
Prophylaxis of migraine headachesu00a0.u00a0

Divalproex sodium extended-release tablets are an extended-release product intended for once-a-day oral administration. Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewed.

Divalproex sodium extended-release tablets are intended for once-a-day oral administration. Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewedu00a0u00a0.
Mania: Initial dose is 25 mg/kg/day, increasing as rapidly as possible to achieve therapeutic response or desired plasma level . The maximum recommended dosage is 60 mg/kg/dayu00a0u00a0.
Complex Partial Seizures: Start at 10 mg/kg/day to 15 mg/kg/day, increasing at 1 week intervals by 5 mg/kg/day to 10 mg/kg/day to achieve optimal clinical response; if response is not satisfactory, check valproate plasma level; see full prescribing information for conversion to monotherapy . The maximum recommended dosage is 60 mg/kg/dayu00a0u00a0.
Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week intervals by 5 mg/kg/day to 10 mg/kg/day until seizure control or limiting side effects . The maximum recommended dosage is 60 mg/kg/dayu00a0u00a0.
Migraine: The recommended starting dose is 500 mg/day for 1 week, thereafter increasing to 1,000 mg/day .

Divalproex sodium extended-release tablets USP,u00a0 are available as white to off-white, round, coated tablets with imprinting u201cAN 755u201d on one side and plain on the other side. Each divalproex sodium extended-release tablet, USPu00a0contains divalproex sodium, USPu00a0equivalent to 250 mg of valproic acid.
Divalproex sodium extended-release tablets USP, are available as white to off-white, capsule shaped, coated tablets with imprinting u201cAN 757u201d on one side and plain on the other side. Each divalproex sodium extended-release tablet, USPu00a0contains divalproex sodium, USPu00a0equivalent to 500 mg of valproic acid.
Tablets: 250 mg and 500 mgu00a0u00a0

No data

Hepatic disease or significant hepatic dysfunctionu00a0u00a0u00a0
Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase u03b3 (POLG)u00a0u00a0. u00a0u00a0
Suspected POLG-related disorder in children under two years of ageu00a0u00a0. u00a0
Known hypersensitivity to the drugu00a0u00a0u00a0
Urea cycle disordersu00a0u00a0u00a0
Prophylaxis of migraine headaches: u00a0Pregnant women, women of childbearing potential not using effective contraceptionu00a0u00a0u00a0

No data

Hepatotoxicity; evaluate high risk populations and monitor serum liver testsu00a0u00a0
Birth defects, decreased IQ, and neurodevelopmental disorders following exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptableu00a0u00a0u00a0.u00a0
Pancreatitis; divalproex sodium extended-release should ordinarily be discontinuedu00a0u00a0
Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release, increase the risk of suicidal thoughts or behavioru00a0u00a0
Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests .u00a0
Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapyu00a0u00a0u00a0.u00a0
Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia. This adverse reaction can also occur in patients using concomitant topiramateu00a0.u00a0
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reaction; discontinue divalproex sodium extended-release u00a0
Somnolence in the elderly can occur. Divalproex sodium extended-release dosage should be increased slowly and with regular monitoring for fluid and nutritional intakeu00a0u00a0

The following serious adverse reactions are described below and elsewhere in the labeling:
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Information on pediatric adverse reactions is presented in section 8.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Most common adverse reactions (reported >5%) are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss (, , ).
The safety and tolerability of valproate in pediatric patients were shown to be comparable to those in adults ().

No data

Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can decrease valproate clearance. Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn ().
Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended ().
Co-administration of valproate can affect the pharmacokinetics of other drugs (e.g. diazepam, ethosuximide, lamotrigine, phenytoin) by inhibiting their metabolism or protein binding displacement ().
Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose ().
Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release ().
Topiramate: Hyperammonemia and encephalopathy (,).

No data

Pregnancy: Divalproex sodium extended-release can cause congenital malformations including neural tube defects, decreased IQ, and u00a0neurodevelopmental disorders u00a0u00a0u00a0
Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicityu00a0u00a0.u00a0
Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolenceu00a0u00a0u00a0

Overdosage with valproate may result in somnolence, heart block, deep coma, and hypernatremia. Fatalities have been reported; however patients have recovered from valproate levels as high as 2,120 mcg/mL.
In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug. The benefit of gastric lavage or emesis will vary with the time since ingestion. General supportive measures should be applied with particular attention to the maintenance of adequate urinary output.
Naloxone has been reported to reverse the CNS depressant effects of valproate overdosage. Because naloxone could theoretically also reverse the antiepileptic effects of valproate, it should be used with caution in patients with epilepsy.

Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:
Divalproex sodium, USP occurs as a white powder with a characteristic odor.
Divalproex sodium extended-release tablets USP, 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets, USP contain divalproex sodium, USP in a once-a-day extended-release formulation equivalent to 250 and 500 mg of valproic acid.
Inactive Ingredients
Divalproex sodium extended-release tablets USP, 250 mg and 500 mg: ammonium hydroxide, ethyl acrylate and methyl methacrylate co-polymer dispersion, hypromellose, iron oxide, isopropyl alcohol, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyvinyl alcohol, propylene glycol, shellac, silicon dioxide, talc, and titanium dioxide.
Meet USP Dissolution Test 10.

No data

Carcinogenesis
Valproate was administered orally to rats and mice at doses of 80 mg/kg/day and 170 mg/kg/day (less than the maximum recommended human dose on a mg/m basis) for two years. The primary findings were an increase in the incidence of subcutaneous fibrosarcomas in high-dose male rats receiving valproate and a dose-related trend for benign pulmonary adenomas in male mice receiving valproate.
Mutagenesis
Valproate was not mutagenic in an bacterial assay (Ames test), did not produce dominant lethal effects in mice, and did not increase chromosome aberration frequency in an cytogenetic study in rats. Increased frequencies of sister chromatid exchange (SCE) have been reported in a study of epileptic children taking valproate; this association was not observed in another study conducted in adults.
Impairment of Fertility
In chronic toxicity studies in juvenile and adult rats and dogs, administration of valproate resulted in testicular atrophy and reduced spermatogenesis at oral doses of 400 mg/kg/day or greater in rats (approximately equal to or greater than the maximum recommended human dose (MRHD) on a mg/m basis) and 150 mg/kg/day or greater in dogs (approximately equal to or greater than the MRHD on a mg/m basis). Fertility studies in rats have shown no effect on fertility at oral doses of valproate up to 350 mg/kg/day (approximately equal to the MRHD on a mg/m basis) for 60 days.

No data

No data

Divalproex sodium extended-release tablets USP, are available as white to off-white, round, coated tablets with imprinting u201cAN 755u201d on one side and plain on the other side. Each divalproex sodium extended-release tablet, USP contains divalproex sodium, USP equivalent to 250 mg of valproic acid in the following package sizes:
Bottles of 100:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 65162-755-10Bottles of 500:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 65162-755-50
Divalproex sodium extended-release tablets USP, are available as white to off-white, capsule shaped, coated tablets with imprinting u201cAN 757u201d on one side and plain on the other side. Each divalproex sodium extended-release tablet, USP contains divalproex sodium, USP equivalent to 500 mg of valproic acid in the following packaging sizes:
Bottles of 100:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 65162-757-10Bottles of 500:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 65162-757-50
Recommended Storage:
Store tablets at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Hepatotoxicity
Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly .
Pancreatitis
Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly .
Birth Defects and Decreased IQ
Inform pregnant women and women of childbearing potential (including girls beginning the onset of puberty) that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed . Advise women to use effective contraception while taking valproate. When appropriate, counsel these patients about alternative therapeutic options. This is particularly important when valproate use is considered for a condition not usually associated with permanent injury or death such as prophylaxis of migraine headache . Advise patients to read the Medication Guide, which appears as the last section of the labeling and .
Pregnancy Registry
Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant.
Encourage women who are taking divalproex sodium extended-release to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 or visit the website, http://www.aedpregnancyregistry.org/ .
Suicidal Thinking and Behavior
Counsel patients, their caregivers, and families that AEDs, including divalproex sodium extended-release, may increase the risk of suicidal thoughts and behavior and to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients, caregivers, and families to report behaviors of concern immediately to the healthcare providers .
Hyperammonemia
Inform patients of the signs and symptoms associated with hyperammonemic encephalopathy and to notify the prescriber if any of these symptoms occur .
CNS Depression
Since valproate products may produce CNS depression, especially when combined with another CNS depressant (e.g., alcohol), advise patients not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.
Multiorgan Hypersensitivity Reactions
Instruct patients that a fever associated with other organ system involvement (rash, lymphadenopathy, etc.) may be drug-related and should be reported to the physician immediately .
Medication Residue in the Stool
Instruct patients to notify their healthcare provider if they notice a medication residue in the stool .
Manufactured by:n n Ahmedabad 382220, INDIA
Distributed by:n Bridgewater, NJ 08807
Rev. 08-2020-09n

Divalproex (n- dye valu2019 proe exn- ) Sodium Extended-Release Tablets, USP
Read this Medication Guide before you start taking divalproex sodium extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about divalproex sodium n- extended-release tablets?
Do not stop taking divalproex sodium extended-release tablets n- without first talking to your healthcare provider.
Stopping divalproex sodium extended-release tablets suddenly can cause serious problems.
Divalproex sodium extended-release tablets n- can cause serious side effects, including:
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
How can I watch for early symptoms of suicidal thoughts and actions?
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop divalproex sodium extended-release tabletsn- without first talking to a healthcare provider.
Stopping divalproex sodium extended-release tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
What are divalproex sodium extended-release tablets?
Divalproex Sodiumn- Extended-release Tablets
Who should not take divalproex sodiumn- extended-release tablets?
Do not take divalproex sodium extended-release tablets if you:
What should I tell my healthcare provider before taking divalproex sodium n- extended-release tablets?
Before you take divalproex sodium extended-release tablets, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take,
Taking divalproex sodium extended-release tablets with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take divalproex sodiumn- extended-release tablets?
What should I avoid while taking divalproex sodiumn- extended-release tablets?
What are the possible side effects of divalproex sodium n- extended-release tablets?
Divalproex sodium extended-release tablets can cause serious side effects including:
Call your healthcare provider right away, if you have any of the symptoms listed above.
The common side effects of divalproex sodium extended-release tabletsn- include:
These are not all of the possible side effects of n . For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store divalproex sodium extended-release tablets?
Keep divalproex sodium extended-release tablets n- and all medicines out of the reach of children.
General information about the safe and effective use of divalproex sodium n- extended-release tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use divalproex sodium extended-release tablets for a condition for which it was not prescribed. Do not give divalproex sodium extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about divalproex sodium extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about divalproex sodium extended-release tablets that is written for health professionals.
For more information, go to www.amneal.com or call 1-877-835-5472.
What are the ingredients in divalproex sodium extended-release tablets?
Active Ingredient: divalproex sodium, USP.
Inactive Ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:n n Ahmedabad 382220, INDIA
Distributed by:n Bridgewater, NJ 08807
Rev. 08-2020-08

NDC 65162-755-10
Divalproex Sodium Extended-release Tablets USP, 250 mg
100 Tablets
Amneal Pharmaceuticals
NDC 65162-757-10
Divalproex Sodium Extended-release Tablets USP, 500 mg
100 Tablets

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Divalproex Sodium (Divalproex Sodium)

Trade Name : Divalproex Sodium

TABLET, EXTENDED RELEASE

Delivery Process

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Divalproex Sodium (Divalproex Sodium)

Trade Name : Divalproex Sodium

TABLET, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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