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Chemistry

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Also known as: 76584-70-8, Valproate semisodium, Epival, Depakote, Sodium divalproate, Semisodium valproate
Molecular Formula
C16H31NaO4
Molecular Weight
310.40  g/mol
InChI Key
MSRILKIQRXUYCT-UHFFFAOYSA-M

Divalproex Sodium
A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.
1 2D Structure

Divalproex Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;2-propylpentanoate;2-propylpentanoic acid
2.1.2 InChI
InChI=1S/2C8H16O2.Na/c2*1-3-5-7(6-4-2)8(9)10;/h2*7H,3-6H2,1-2H3,(H,9,10);/q;;+1/p-1
2.1.3 InChI Key
MSRILKIQRXUYCT-UHFFFAOYSA-M
2.1.4 Canonical SMILES
CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. 2 Propylpentanoic Acid

2. 2-propylpentanoic Acid

3. Calcium Valproate

4. Convulsofin

5. Depakene

6. Depakine

7. Depakote

8. Dipropyl Acetate

9. Divalproex

10. Ergenyl

11. Magnesium Valproate

12. Propylisopropylacetic Acid

13. Semisodium Valproate

14. Sodium Valproate

15. Valproate

16. Valproate Calcium

17. Valproate Sodium

18. Valproic Acid

19. Valproic Acid, Sodium Salt (2:1)

20. Vupral

2.2.2 Depositor-Supplied Synonyms

1. 76584-70-8

2. Valproate Semisodium

3. Epival

4. Depakote

5. Sodium Divalproate

6. Semisodium Valproate

7. Sprinkle

8. Abbott 50711

9. Divalproex

10. Valdisoval

11. Valproato Semisodico

12. Delepsine

13. Valcote

14. Valparin

15. Epilex

16. Valproate Semisodique

17. Sodium Hydrogen Divalproate

18. Valproatum Seminatricum

19. Sodium Hydrogen Bis(2-propylpentanoate)

20. Pentanoic Acid, 2-propyl-, Sodium Salt (2:1)

21. Abbott-50711

22. Sodium Hydrogen Bis(2-propylvalerate)

23. Divalproex Sodium [usan:usp]

24. Divalproex (sodium)

25. Sodium;2-propylpentanoate;2-propylpentanoic Acid

26. Valproate Semisodium (inn)

27. Depakote Er

28. Chebi:4667

29. Divalproate

30. Valproic Acid (semisodium Salt)

31. Depakote Cp

32. Valproate Semisodium [inn]

33. Valproate Semisodique [french]

34. Valproato Semisodico [spanish]

35. Valproatum Seminatricum [latin]

36. Valproic Acid Semisodium Salt

37. Depakote (tn)

38. Natrium Hydrogen Bis(2-propylvalerat)

39. Valproic Acid Semisodium Salt (2:1)

40. 644vl95ao6

41. Valproic Acid Sodium Salt (2:1)

42. Divalproex Sodium (usp)

43. Unii-644vl95ao6

44. Sodium Divalproex

45. Sodium Hydrogen Bis(2-propylvalerate), Oligomer

46. Sodium; 2-propylpentanoate; 2-propylpentanoic Acid

47. Schembl40996

48. Chembl2105613

49. Sodium;hydron;2-propylpentanoate

50. Dtxsid70227388

51. Hms3651c17

52. Hms3884o06

53. Bcp12800

54. S1703

55. Sodiumhydrogenbis(2-propylpentanoate)

56. Akos015895200

57. Ccg-267581

58. As-17254

59. Db-056089

60. Ft-0625375

61. Sw219169-1

62. C76453

63. D00304

64. Ab01568255_01

65. A838751

66. Sodium 2-propylpentanoate--2-propylpentanoic Acid (1:1)

2.3 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 310.40 g/mol
Molecular Formula C16H31NaO4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count10
Exact Mass310.21200375 g/mol
Monoisotopic Mass310.21200375 g/mol
Topological Polar Surface Area77.4 Ų
Heavy Atom Count21
Formal Charge0
Complexity192
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameDepakote
Drug LabelDivalproex 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 d...
Active IngredientDivalproex sodium
Dosage FormCapsule, delayed rel pellets; Tablet, delayed release
RouteOral
Strengtheq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market StatusPrescription
CompanyAbbvie

2 of 6  
Drug NameDepakote er
Drug LabelDivalproex 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 d...
Active IngredientDivalproex sodium
Dosage FormTablet, extended release
Routeoral; Oral
Strength250mg; eq 500mg valproic acid; eq 250mg valproic acid; 500mg
Market StatusPrescription
CompanyAbbott; Abbvie

3 of 6  
Drug NameDivalproex sodium
Drug LabelDivalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:Di...
Active IngredientDivalproex sodium
Dosage FormTablet, extended release; Capsule, delayed rel pellets; Tablet, delayed release
RouteOral
Strengtheq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market StatusPrescription
CompanyAnchen Pharms; Wockhardt; Upsher Smith; Nu Pharm; Actavis Labs Fl; Teva; Vintage; Aurobindo Pharma; Sun Pharm Inds; Reddys; Lupin; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare; Mylan; Unichem Labs; Impax Labs

4 of 6  
Drug NameDepakote
Drug LabelDivalproex 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 d...
Active IngredientDivalproex sodium
Dosage FormCapsule, delayed rel pellets; Tablet, delayed release
RouteOral
Strengtheq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market StatusPrescription
CompanyAbbvie

5 of 6  
Drug NameDepakote er
Drug LabelDivalproex 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 d...
Active IngredientDivalproex sodium
Dosage FormTablet, extended release
Routeoral; Oral
Strength250mg; eq 500mg valproic acid; eq 250mg valproic acid; 500mg
Market StatusPrescription
CompanyAbbott; Abbvie

6 of 6  
Drug NameDivalproex sodium
Drug LabelDivalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:Di...
Active IngredientDivalproex sodium
Dosage FormTablet, extended release; Capsule, delayed rel pellets; Tablet, delayed release
RouteOral
Strengtheq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid
Market StatusPrescription
CompanyAnchen Pharms; Wockhardt; Upsher Smith; Nu Pharm; Actavis Labs Fl; Teva; Vintage; Aurobindo Pharma; Sun Pharm Inds; Reddys; Lupin; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare; Mylan; Unichem Labs; Impax Labs

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)


Antimanic Agents

Agents that are used to treat bipolar disorders or mania associated with other affective disorders. (See all compounds classified as Antimanic Agents.)


Enzyme Inhibitors

Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)


GABA Agents

Substances used for their pharmacological actions on GABAergic systems. GABAergic agents include agonists, antagonists, degradation or uptake inhibitors, depleters, precursors, and modulators of receptor function. (See all compounds classified as GABA Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]; Mood Stabilizer [EPC]; Anti-epileptic Agent [EPC]

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RD LUZHU DISTTAOY UAN CITY 33856 TAIWANSDNF TAIWAN","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709922600,"product":"SODIUM VALPROATE IP\/PH.EUR","address":"54-A, SIR MATHURADAS VASANJI ROAD","city":"MUMBAI, MAHARASHTRA","supplier":"SANOFI","supplierCountry":"FRANCE","foreign_port":"FOS SUR MER","customer":"SANOFI","customerCountry":"INDIA","quantity":"6014.36","actualQuantity":"6014.36","unit":"KGS","unitRateFc":"26.2","totalValueFC":"174397.8","currency":"EUR","unitRateINR":"2407.8","date":"09-Mar-2024","totalValueINR":"14481255.72","totalValueInUsd":"174397.8","indian_port":"JNPT","hs_no":"29159099","bill_no":"2495757","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FOS SUR MER","supplierAddress":"38 BEACH ROAD #18-11, SOUTH BEACH TOWER SINGAPORE 189767 SingaporeSDNF Singapore","customerAddress":"54-A, SIR MATHURADAS VASANJI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710959400,"product":"DIVALPROEX SODIUM","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"KATWIJK CHEMIE","supplierCountry":"NETHERLANDS","foreign_port":"ROTTERDAM","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"42.5","totalValueFC":"214709.8","currency":"USD","unitRateINR":"3565.7","date":"21-Mar-2024","totalValueINR":"17828600","totalValueInUsd":"214709.8","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29159099","bill_no":"1000858","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"P.O BOX 3001,2220 CA KATWIJK THE NETHERLANS NL","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718649000,"product":"SODIUM VALPROATE PH EUR(FOR ORAL SOLUTION) (QTY:108 KGS) ASPER INV","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"SCI PHARMTECH","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"108.00","actualQuantity":"108","unit":"KGS","unitRateFc":"45.6","totalValueFC":"5968.4","currency":"USD","unitRateINR":"4613.3","date":"18-Jun-2024","totalValueINR":"498234.77","totalValueInUsd":"5968.4","indian_port":"Hyderabad Air","hs_no":"29159099","bill_no":"4064061","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"NO.61 LN 309 HAIHU N RD LUZHU DISTTAOYUAN CITY 33856 TAIWANSDNF Taiwan, Province of China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720204200,"product":"DIVALPROEX SODIUM (QTY:400 BAGS X 25 KG PER BAG = 10000 KGS) ASPER INV","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"KATWIJK CHEMIE","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"42.2","totalValueFC":"425322","currency":"USD","unitRateINR":"3555.3","date":"06-Jul-2024","totalValueINR":"35553125","totalValueInUsd":"425322","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29159070","bill_no":"1002195","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"AMSTERDAM","supplierAddress":"P.O BOX 3001,2220 CA KATWIJK THE NETHERLANS NL","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726252200,"product":"SODIUM VALPROATE PH EUR (FOR ORAL SOLUTION) (QTY:180 KGS) ASPER INV","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"SCI PHARMTECH","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"180.00","actualQuantity":"180","unit":"KGS","unitRateFc":"45.6","totalValueFC":"9979.5","currency":"USD","unitRateINR":"4646.1","date":"14-Sep-2024","totalValueINR":"836296.04","totalValueInUsd":"9979.5","indian_port":"Hyderabad Air","hs_no":"29159099","bill_no":"5602218","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"NO.61 LN 309 HAIHU N RD LUZHU DIST TAOYUAN CITY 33856 TAIWAN SDNF Taiwan, Province of China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]
06-Jan-2021
30-Oct-2024
KGS
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Average Price (USD/KGS)

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Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

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Drugs in Development

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Details:

CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for pulmonary arterial hypertension.


Lead Product(s): Divalproex Sodium,Sodium Valproate

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: CS1

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 30, 2024

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01

Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Details : CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for pulmonary arterial hypertension.

Brand Name : CS1

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 30, 2024

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FDF Dossiers

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Sanofi

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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Regulatory Info :

Registration Country : Italy

Valproic Acid

Brand Name : Depakin

Dosage Form : Valproic Acid+Sodium Valproate 1.000Mg 30 Joined' Oral Use Rm

Dosage Strength : os grat 30 bust 1,000 mg modified release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Sanofi

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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Regulatory Info :

Registration Country : Italy

Valproic Acid

Brand Name : Depakin

Dosage Form : Valproic Acid+Sodium Valproate 250Mg 30 Joined' Oral Use Rm

Dosage Strength : os grat 30 bust 250 mg modified release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Sanofi

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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Regulatory Info :

Registration Country : Italy

Valproic Acid

Brand Name : Depakin Chrono

Dosage Form : Valproic Acid+Sodium Valproate 500Mg 30 Joined' Oral Use Rp

Dosage Strength : 30 CPR 500 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Sanofi

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Regulatory Info :

Registration Country : Switzerland

Acidum valproicum; sodium valproas

Brand Name : Depakine Chrono

Dosage Form : Film-Coated Tablets

Dosage Strength : 300mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Sanofi

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Regulatory Info :

Registration Country : Switzerland

Acidum valproicum; sodium valproas

Brand Name : Valproate Chrono Sanofi

Dosage Form : Filmtabl

Dosage Strength : 500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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06

Sanofi

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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Valproic Acid

Brand Name : Epilim CR 200

Dosage Form : TAB

Dosage Strength : 200mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Sanofi

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Valproic Acid

Brand Name : Epilim Intravenous

Dosage Form : INJ

Dosage Strength : 400mg/4ml

Packaging : 4X1mg/4ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Sanofi

France
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Regulatory Info :

Registration Country : Australia

valproate

Brand Name : Epilim Syrup

Dosage Form : oral

Dosage Strength : 200 mg/5 mL

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

Sanofi

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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Regulatory Info :

Registration Country : Australia

valproate

Brand Name : Valproate Winthrop EC 200

Dosage Form :

Dosage Strength :

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Sanofi

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
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Regulatory Info :

Registration Country : Australia

valproate

Brand Name : Valproate Winthrop EC 500

Dosage Form :

Dosage Strength :

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 250MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18081

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DOSAGE - SYRUP;ORAL - 250MG/5ML **Federal Reg...DOSAGE - SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18082

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 12...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID

USFDA APPLICATION NUMBER - 18723

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 25...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID

USFDA APPLICATION NUMBER - 18723

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 50...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID

USFDA APPLICATION NUMBER - 18723

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DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID

USFDA APPLICATION NUMBER - 19680

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID

USFDA APPLICATION NUMBER - 21168

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID

USFDA APPLICATION NUMBER - 21168

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