GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25838
Submission : 2012-02-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9557
Submission : 1992-02-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20329
Submission : 2007-03-06
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10958
Submission : 1994-06-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28074
Submission : 2014-03-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16190
Submission : 2002-10-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15712
Submission : 2001-11-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28266
Submission : 2014-05-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32603
Submission : 2018-03-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30976
Submission : 2016-09-20
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
STARCH
Route : BUCCAL
CAS : 9005-25-8
UNII : NA
Potency Amount : 22.5
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STARCH
Route : BUCCAL/SUBLINGUAL
CAS : 9005-25-8
UNII : NA
Potency Amount : 14.19
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STARCH
Route : INTRAMUSCULAR
CAS : 9005-25-8
UNII : NA
Potency Amount : 0.6
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STARCH
Route : ORAL
CAS : 9005-25-8
UNII : NA
Potency Amount : 605
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STARCH
Route : ORAL
CAS : 9005-25-8
UNII : NA
Potency Amount : 25
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STARCH
Route : ORAL
CAS : 9005-25-8
UNII : NA
Potency Amount : 43.5
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STARCH
Route : ORAL
CAS : 9005-25-8
UNII : NA
Potency Amount : 36.4
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STARCH
Route : ORAL
CAS : 9005-25-8
UNII : NA
Potency Amount : 33.5
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STARCH
Route : ORAL
CAS : 9005-25-8
UNII : NA
Potency Amount : 15.5
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STARCH
Route : ORAL
CAS : 9005-25-8
UNII : NA
Potency Amount : 65.2
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Application : Direct Compression
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Starch
Application : Direct Compression
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Starch
Application : Direct Compression
Excipient Details : Capsule Filling, Direct Compression, Binding, Disintegration
Pharmacopoeia Ref : Not Available
Technical Specs : EXCiPACT
Ingredient(s) : Native & Pregelatinized Corn Starch
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