Activella (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

HD Carton
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HD Pouch
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HD Face Card
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PRINCIPAL DISPLAY PANEL

LD CARTON
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LD POUCH
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LD FACE CARD
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ACTIVELLA estradiol/norethindrone acetate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60846-232
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 1 mg
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
COPOVIDONE K25-31
TALC
MAGNESIUM STEARATE
HYPROMELLOSES
TRIACETIN
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code ALH
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60846-232-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60846-232-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020907 05/01/2019
ACTIVELLA estradiol/norethindrone acetate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60846-231
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.5 mg
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 0.1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
TALC
MAGNESIUM STEARATE
HYPROMELLOSES
TRIACETIN
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code ALL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60846-231-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60846-231-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020907 05/01/2019
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 analysis (60846-232), analysis (60846-231), label (60846-232), label (60846-231), manufacture (60846-232), manufacture (60846-231), pack (60846-232), pack (60846-231)

Revised: 08/2021 Amneal Pharmaceuticals LLC

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