GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35106
Submission : 2020-08-26
Status : Active
Type : IV
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 : 35664
Submission : 2021-02-25
Status : Active
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35942
Submission : 2021-05-27
Status : Active
Type : IV
NDC Package Code : 0406-5853
Start Marketing Date : 2013-04-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35106
Submission : 2020-08-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35942
Submission : 2021-05-27
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35664
Submission : 2021-02-25
Status : Active
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FINISHED DOSAGE FORMULATIONS
CALCIUM STEARATE
Route : BUCCAL/SUBLINGUAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 1.42
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
CALCIUM STEARATE
Route : ORAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 21.1
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
CALCIUM STEARATE
Route : ORAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 3.2
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
CALCIUM STEARATE
Route : ORAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 1
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
CALCIUM STEARATE
Route : ORAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 91.9
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
CALCIUM STEARATE
Route : ORAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 30
Potency Unit : MG/1GM
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
CALCIUM STEARATE
Route : ORAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 42.9
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
CALCIUM STEARATE
Route : ORAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 47.5
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
CALCIUM STEARATE
Route : ORAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 1
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
CALCIUM STEARATE
Route : ORAL
CAS : 1592-23-0
UNII : 776XM7047L
Potency Amount : 4.8
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
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10 Jun 2024
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28 Oct 2023
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13 Jan 2021