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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
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
Digital Content
Website
Corporate PDF
FINISHED DOSAGE FORMULATIONS
SORBITOL
Route : BUCCAL
CAS : 50704
UNII : 506T60A25R
Potency Amount : 257
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : DENTAL
CAS : 50704
UNII : 506T60A25R
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRA-ARTICULAR
CAS : 50704
UNII : 506T60A25R
Potency Amount : 84.83
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRALESIONAL
CAS : 50704
UNII : 506T60A25R
Potency Amount : 45
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRAMUSCULAR
CAS : 50704
UNII : 506T60A25R
Potency Amount : 84.83
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRASYNOVIAL
CAS : 50704
UNII : 506T60A25R
Potency Amount : 84.83
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRAVENOUS
CAS : 50704
UNII : 506T60A25R
Potency Amount : 22.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRAVENOUS
CAS : 50704
UNII : 506T60A25R
Potency Amount : 5.43
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRAVENOUS
CAS : 50704
UNII : 506T60A25R
Potency Amount : 48
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : IV(INFUSION)
CAS : 50704
UNII : 506T60A25R
Potency Amount : 4.7
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
MARKET PLACE
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16 Jun 2023
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08 Dec 2022
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01 Jul 2022
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28 Apr 2022
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14 Apr 2022
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22 Feb 2022
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14 Jun 2021
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25 May 2021
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06 Apr 2021
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20 Mar 2021
REF. STANDARDS & IMPURITIES
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