GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32710
Submission : 2018-03-30
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 : 32710
Submission : 2018-03-30
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 : TRANEXAMIC ACID
Dosage Form : TABLET; ORAL
Application Number : 202093
Country : US
Patented : No

Drug : PANTOPRAZOLE SODIUM
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Application Number : 90797
Country : US
Patented : No

Drug : ZOLPIDEM TARTRATE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 90153
Country : US
Patented : No

Drug : RISPERIDONE
Dosage Form : TABLET, ORALLY DISINTEGRATING; ORAL
Application Number : 91537
Country : US
Patented : No

Drug : OMEPRAZOLE
Dosage Form : TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE; ORAL
Application Number : 209400
Country : US
Patented : Yes

Drug : PROPRANOLOL HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 78022
Country : US
Patented : No

Drug : MIRTAZAPINE
Dosage Form : TABLET, ORALLY DISINTEGRATING; ORAL
Application Number : 76901
Country : US
Patented : No

Drug : FAZACLO ODT
Dosage Form : TABLET, ORALLY DISINTEGRATING; ORAL
Application Number : 21590
Country : US
Patented : No

Drug : RISPERIDONE
Dosage Form : TABLET, ORALLY DISINTEGRATING; ORAL
Application Number : 90839
Country : US
Patented : No

Drug : ATORVASTATIN CALCIUM
Dosage Form : TABLET; ORAL
Application Number : 91624
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
Application : Taste Masking
Excipient Details : Polygit E100 is used as a taste and odor masking agent in oral solid immediate-release formulations such as pellets and tablets.
Pharmacopoeia Ref : USP/NF, JPE, Ph. Eur.
Technical Specs : Soluble in gastric fluid up to pH 5
Ingredient(s) : Amino Methacrylate Copolymer
Application : Taste Masking
Excipient Details : Acrycoat EPO is used as a taste-masking agent in various OSDs.
Pharmacopoeia Ref : USP/NF: Amino Methacrylate Cop...
Technical Specs : Not Available
Ingredient(s) : Amino Methacrylate Copolymer