GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21367
Submission : 2008-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37646
Submission : 2022-11-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35753
Submission : 2021-08-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35823
Submission : 2021-06-07
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33397
Submission : 2018-12-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33593
Submission : 2019-02-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7950
Submission : 1989-02-16
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21367
Submission : 2008-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35753
Submission : 2021-08-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7950
Submission : 1989-02-16
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37646
Submission : 2022-11-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33593
Submission : 2019-02-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33397
Submission : 2018-12-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35823
Submission : 2021-06-07
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : ATORVASTATIN CALCIUM
Dosage Form : TABLET; ORAL
Application Number : 207687
Country : US
Patented : No
Drug : ATORVASTATIN CALCIUM
Dosage Form : TABLET; ORAL
Application Number : 214969
Country : US
Patented : No
Drug : METAXALONE
Dosage Form : TABLET; ORAL
Application Number : 203399
Country : US
Patented : No
Drug : ESOMEPRAZOLE STRONTIUM
Dosage Form : CAPSULE, DELAYED RELEASE; ORAL
Application Number : 202342
Country : US
Patented : No
Drug : ATORVASTATIN CALCIUM
Dosage Form : TABLET; ORAL
Application Number : 204991
Country : US
Patented : No
Drug : NICOTINE POLACRILEX
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 76777
Country : US
Patented : No
Drug : NICOTINE POLACRILEX
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 76775
Country : US
Patented : No
Drug : NICOTINE POLACRILEX
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 91354
Country : US
Patented : No
Drug : NICOTINE POLACRILEX
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 91349
Country : US
Patented : No
Drug : NICOTINE POLACRILEX
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 78546
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
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) : Calcium Carbonate Excipient
Application : Direct Compression
Excipient Details : CM90 is a directly compressible, granulated calcium carbonate with maltodextrin used for swallow tablets due to its high density and compressibility.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 490- 500 µm; Tapped Density: 1.50
Ingredient(s) : Calcium Carbonate Excipient
Application : Direct Compression
Excipient Details : Vitasmooth is a directly compressible calcium carbonate preformulated with excipients used for the production of chewable or antacid meltaway tablets.
Pharmacopoeia Ref : NA
Technical Specs : Tapped Density: 0.80, PSD D50: 150 µm
Ingredient(s) : Calcium Carbonate Excipient
Application : Fillers, Diluents & Binders
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) : Calcium Carbonate Excipient
Application : Fillers, Diluents & Binders
Excipient Details : CM90 is a directly compressible, granulated calcium carbonate with maltodextrin used for swallow tablets due to its high density and compressibility.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 490- 500 µm; Tapped Density: 1.50
Ingredient(s) : Calcium Carbonate Excipient
Brand Name : Calcium carbonate
Application : Fillers, Diluents & Binders
Excipient Details : Calcium Carbonate is used as buffering agent, Antacid, Calcium Supplement. It is also used as Dry binder, diluents and dissolution aid in tablets.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Calcium Carbonate Excipient
MARKET PLACE
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