GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28619
Submission : 2014-09-29
Status : Active
Type : IV
NDC Package Code : 55363-464
Start Marketing Date : 2013-10-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FINISHED DOSAGE FORMULATIONS
Drug : EXSERVAN
Dosage Form : FILM; ORAL
Application Number : 212640
Country : US
Patented : No
Drug : NICORETTE (MINT)
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 20066
Country : US
Patented : No
Drug : NICORETTE
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 20066
Country : US
Patented : Yes
Drug : NICORETTE (MINT)
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 18612
Country : US
Patented : No
Drug : NICORETTE
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 18612
Country : US
Patented : Yes
Drug : NICORETTE
Dosage Form : TROCHE/LOZENGE; ORAL
Application Number : 21330
Country : US
Patented : No
Drug : NICOTINE POLACRILEX
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 76779
Country : US
Patented : No
Drug : NICOTINE POLACRILEX
Dosage Form : GUM, CHEWING; BUCCAL
Application Number : 78967
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 : 78546
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
Application : Taste Masking
Excipient Details : It is used in taste masking of nicotine polacrilex.