GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 22662
Submission : 2009-03-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14823
Submission : 2000-04-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29965
Submission : 2015-10-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32980
Submission : 2018-07-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29457
Submission : 2015-03-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24006
Submission : 2010-07-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31077
Submission : 2016-10-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23703
Submission : 2010-04-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30189
Submission : 2016-01-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24399
Submission : 2010-11-24
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Coating Systems & Additives
Excipient Details : It is a dry powder derived from a 30% aqueous dispersion (ECOPOL L 30 D 55). The major application is for Enteric/Delayed release coating for drug delivery in the duodenum.
Pharmacopoeia Ref : Monograph - EP, USP, JPE
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Coating Systems & Additives
Excipient Details : It is a ready to use 30% dispersion in water and its major application is for Enteric/Delayed release coating for drug delivery in the duodenum.
Pharmacopoeia Ref : Monograph - EP, USP, JPE
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Coating Systems & Additives
Excipient Details : Enteric Coating (Drug delivery in Jejunum)
Pharmacopoeia Ref : USP/NF: Methacrylic Acid Copol...
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid Copolymer Type A
Brand Name : Instacoat EN Super II
Application : Coating Systems & Additives
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid Copolymer Type C
Brand Name : Instacoat EN Super IV
Application : Coating Systems & Additives
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Coating Systems & Additives
Excipient Details : It is an anionic copolymer used in delayed and sustained release coatings to enhance solubility for poorly soluble drugs in solid oral dosage forms such as tablets, capsules, etc.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Coating Systems & Additives
Excipient Details : Enteric, Delayed Release Matrix and Solubility Enhancement
Pharmacopoeia Ref : Multicompendial
Technical Specs : Methylacryli acid and Ethyl Acrylate copolymer (1:1) Type A
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Coating Systems & Additives
Excipient Details : Enteric Coating (Drug delivery in Jejunum)
Pharmacopoeia Ref : USP/NF: Methacrylic Acid Copol...
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid Copolymer Type C
Application : Coating Systems & Additives
Excipient Details : Enteric Coating (Drug delivery in Jejunum)
Pharmacopoeia Ref : Ph.Eur.: Methacrylic Acid - Et...
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Coating Systems & Additives
Brand Name : Kollicoat MAE 100-55
Application : Coating Systems & Additives
Excipient Details : Enteric coating with release above pH 5.5 (non-neutralized powder), fast redispersing for aqueaous and organic coating
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid & Ethyl Acrylate Copolymer
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