GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33618
Submission : 2019-02-23
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : ASACOL HD
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Application Number : 21830
Country : US
Patented : No
Drug : KADIAN
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 20616
Country : US
Patented : No
Drug : DIMETHYL FUMARATE
Dosage Form : CAPSULE, DELAYED RELEASE; ORAL
Application Number : 210499
Country : US
Patented : No
Drug : ZOLPIDEM TARTRATE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 78179
Country : US
Patented : No
Drug : GLIPIZIDE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 76467
Country : US
Patented : No
Drug : BUDESONIDE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 205457
Country : US
Patented : No
DEXMETHYLPHENIDATE HYDROCHLORIDE
Drug : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 215523
Country : US
Patented : No
Drug : NEXIUM 24HR
Dosage Form : CAPSULE, DELAYED RELEASE; ORAL
Application Number : 204655
Country : US
Patented : No
Drug : ANAPROX DS
Dosage Form : TABLET; ORAL
Application Number : 18164
Country : US
Patented : No
Drug : ANAPROX
Dosage Form : TABLET; ORAL
Application Number : 18164
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS