Adefovir Dipivoxil (Page 9 of 9)

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APOTEX INC.
Adefovir Dipivoxil Tablets 10 mg

Manufactured By: Manufactured For:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 USA 33326

Revised: January 2019

Rev. 3

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 10MG LABEL

APOTEX CORP. NDC 60505-3947-3

Adefovir Dipivoxil Tablets, 10 mg

30 tablets

Rx only

draft-label-10mg-30s
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 10MG CARTON

APOTEX CORP. NDC 60505-3947-3

Adefovir Dipivoxil Tablets, 10 mg

30 tablets

Rx only

draft-carton-10mg-30s
(click image for full-size original)
ADEFOVIR DIPIVOXIL adefovir dipivoxil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3947
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADEFOVIR DIPIVOXIL (adefovir) ADEFOVIR DIPIVOXIL 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code APO;A10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-3947-3 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (60505-3947-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205459 09/25/2018
Labeler — Apotex Corp. (845263701)
Registrant — Apotex Inc. (209429182)

Revised: 06/2020 Apotex Corp.

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