GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6244
Submission : 1986-04-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2001-114 - Rev 04
Issue Date : 2021-04-09
Type : Chemical
Substance Number : 436
Status : Valid
NDC Package Code : 50516-005
Start Marketing Date : 2021-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3298
Submission : 1978-09-07
Status : Inactive
Type : IV
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Corporate PDF
Certificate Number : R1-CEP 2001-113 - Rev 02
Issue Date : 2019-12-05
Type : Chemical
Substance Number : 435
Status : Valid
NDC Package Code : 50516-005
Start Marketing Date : 2021-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6244
Submission : 1986-04-03
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3298
Submission : 1978-09-07
Status : Inactive
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
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Website
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Sorbitol, liquid (crystallising)
Certificate Number : R1-CEP 2001-114 - Rev 04
Status : Valid
Issue Date : 2021-04-09
Type : Chemical
Substance Number : 436
Certificate Number : R1-CEP 2001-113 - Rev 02
Status : Valid
Issue Date : 2019-12-05
Type : Chemical
Substance Number : 435
NDC Package Code : 50516-005
Start Marketing Date : 2021-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
FINISHED DOSAGE FORMULATIONS
Drug : DEPAKENE
Dosage Form : CAPSULE; ORAL
Application Number : 18081
Country : US
Patented : No
Drug : LEXAPRO
Dosage Form : SOLUTION; ORAL
Application Number : 21365
Country : US
Patented : No
Drug : CARAFATE
Dosage Form : SUSPENSION; ORAL
Application Number : 19183
Country : US
Patented : No
Drug : DEPAKENE
Dosage Form : SYRUP; ORAL
Application Number : 18082
Country : US
Patented : No
Drug : CYCLOSPORINE
Dosage Form : SOLUTION; ORAL
Application Number : 65054
Country : US
Patented : No
Drug : CYCLOSPORINE
Dosage Form : CAPSULE; ORAL
Application Number : 65044
Country : US
Patented : No
Drug : CARBAMAZEPINE
Dosage Form : TABLET, CHEWABLE; ORAL
Application Number : 75687
Country : US
Patented : No
Drug : FELBAMATE
Dosage Form : SUSPENSION; ORAL
Application Number : 206314
Country : US
Patented : No
Drug : CARBAMAZEPINE
Dosage Form : TABLET; ORAL
Application Number : 74649
Country : US
Patented : No
Drug : DESLORATADINE
Dosage Form : SOLUTION; ORAL
Application Number : 202592
Country : US
Patented : No
SORBITOL
Route : BUCCAL
CAS : 50704
UNII : 506T60A25R
Potency Amount : 257
Potency Unit : MG
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SORBITOL
Route : DENTAL
CAS : 50704
UNII : 506T60A25R
Potency Amount : 0
Potency Unit : NA
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SORBITOL
Route : INTRA-ARTICULAR
CAS : 50704
UNII : 506T60A25R
Potency Amount : 84.83
Potency Unit : %
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SORBITOL
Route : INTRALESIONAL
CAS : 50704
UNII : 506T60A25R
Potency Amount : 45
Potency Unit : %
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SORBITOL
Route : INTRAMUSCULAR
CAS : 50704
UNII : 506T60A25R
Potency Amount : 84.83
Potency Unit : %
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SORBITOL
Route : INTRASYNOVIAL
CAS : 50704
UNII : 506T60A25R
Potency Amount : 84.83
Potency Unit : %
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Product Web Link
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Corporate PDF
SORBITOL
Route : INTRAVENOUS
CAS : 50704
UNII : 506T60A25R
Potency Amount : 22.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
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Corporate PDF
SORBITOL
Route : INTRAVENOUS
CAS : 50704
UNII : 506T60A25R
Potency Amount : 5.43
Potency Unit : %
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Product Web Link
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Corporate PDF
SORBITOL
Route : INTRAVENOUS
CAS : 50704
UNII : 506T60A25R
Potency Amount : 48
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
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Website
Corporate PDF
SORBITOL
Route : IV(INFUSION)
CAS : 50704
UNII : 506T60A25R
Potency Amount : 4.7
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
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Corporate PDF
EXCIPIENTS BY APPLICATIONS
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/USP, USP/FCC
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Brand Name : NEOSORB® 70/02 SB
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/USP
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : USP/FCC, EP/USP
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/NF
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid non crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Brand Name : NEOSORB® 70/70 SB
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/NF
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid non crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : NF
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid non crystallizing
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Brand Name : ReadiLYCOAT® D CLEAR 110.01
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Dosage Form : Cream / Lotion / Ointment, Softgels
Grade : Oral and Topical
Category : Film Formers & Plasticizers
Application : Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D CLEAR 110.01 MS
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Brand Name : POLYSORB® 85/70/00
Application : Film Formers & Plasticizers
Excipient Details : It is a plasticizer in soft capsules and orally dissolving films. It can be used in pharmaceutical dosage forms.
Pharmacopoeia Ref : EP/USP
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid, partially dehydrated
Brand Name : ReadiLYCOAT® D WHITE 010.01
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
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