FESOTERODINE FUMARATE (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 4 mg (30 Tablets Bottle)

NDC65862-766-30
Rx only
Fesoterodine Fumarate
Extended-release Tablets
4 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 4 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 8 mg (30 Tablets Bottle)

NDC 65862-767-30
Rx only
Fesoterodine Fumarate
Extended-release Tablets
8 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 8 mg (30 Tablets Bottle)
(click image for full-size original)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 8 mg (30 Tablets Bottle)
FESOTERODINE FUMARATE fesoterodine fumarate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-766
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FESOTERODINE FUMARATE (FESOTERODINE) FESOTERODINE FUMARATE 4 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
GLYCERYL DIBEHENATE
HYPROMELLOSE 2208 (100000 MPA.S)
HYPROMELLOSE 2208 (4000 MPA.S)
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MICROCRYSTALLINE CELLULOSE 112
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color BLUE (ligth blue) Score no score
Shape OVAL (biconvex) Size 13mm
Flavor Imprint Code K46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-766-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205007 06/17/2022
FESOTERODINE FUMARATE fesoterodine fumarate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-767
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FESOTERODINE FUMARATE (FESOTERODINE) FESOTERODINE FUMARATE 8 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
GLYCERYL DIBEHENATE
HYPROMELLOSE 2208 (100000 MPA.S)
HYPROMELLOSE 2208 (4000 MPA.S)
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MICROCRYSTALLINE CELLULOSE 112
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color BLUE Score no score
Shape OVAL (biconvex) Size 13mm
Flavor Imprint Code K47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-767-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205007 06/17/2022
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-766), ANALYSIS (65862-767), MANUFACTURE (65862-766), MANUFACTURE (65862-767)

Revised: 06/2022 Aurobindo Pharma Limited

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