GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32987
Submission : 2018-07-11
Status : Active
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32987
Submission : 2018-07-11
Status : Active
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FINISHED DOSAGE FORMULATIONS
Drug : NEXICLON XR
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 22500
Country : US
Patented : Yes
Drug : DEXTROMETHORPHAN POLISTIREX
Dosage Form : SUSPENSION, EXTENDED RELEASE; ORAL
Application Number : 203133
Country : US
Patented : No

Drug : KARBINAL ER
Dosage Form : SUSPENSION, EXTENDED RELEASE; ORAL
Application Number : 22556
Country : US
Patented : Yes

Drug : ADZENYS XR-ODT
Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Application Number : 204326
Country : US
Patented : Yes

Drug : ADZENYS ER
Dosage Form : SUSPENSION, EXTENDED RELEASE; ORAL
Application Number : 204325
Country : US
Patented : Yes

Drug : QUILLICHEW ER
Dosage Form : TABLET, EXTENDED RELEASE, CHEWABLE; ORAL
Application Number : 207960
Country : US
Patented : Yes

Drug : QUILLIVANT XR
Dosage Form : FOR SUSPENSION, EXTENDED RELEASE; ORAL
Application Number : 202100
Country : US
Patented : Yes

Drug : DEXTROMETHORPHAN POLISTIREX
Dosage Form : SUSPENSION, EXTENDED RELEASE; ORAL
Application Number : 91135
Country : US
Patented : No

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Drug : DYANAVEL XR 15
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 210526
Country : US
Patented : Yes

Drug : CLONIDINE
Dosage Form : SUSPENSION, EXTENDED RELEASE; ORAL
Application Number : 22499
Country : US
Patented : No

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EXCIPIENTS BY APPLICATIONS
Dosage Form : Capsule, Granule / Pellet, Orodispersible Tablet, Tablet
Grade : Not Available
Category : Granulation
Application : Granulation
Excipient Details : Wet Granulation and Direct Compression
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Sodium Polystyrene Sulphonate Excipient
Dosage Form : Granule / Pellet, Orodispersible Tablet, Tablet
Grade : Not Available
Category : Direct Compression
Application : Direct Compression
Excipient Details : Wet Granulation and Direct Compression
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Sodium Polystyrene Sulphonate Excipient
Application : Taste Masking
Excipient Details : Wet Granulation and Direct Compression
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Sodium Polystyrene Sulphonate Excipient