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Package Insert and Label Information: Tenofovir Disoproxil Fumarate

By PharmaChem Technologies (Grand Bahama) Ltd. | Last revised: 17 September 2009

TENOFOVIR DISOPROXIL FUMARATE — tenofovir disoproxil fumarate powder
PharmaChem Technologies (Grand Bahama) Ltd.

PHARMACHEM TECHNOLOGIES, GRAND BAHAMA LIMITED

West Sunrise Highway, P.O. Box F 42430 , Freeport, Bahamas

Tenofovir disoproxil fumarate GS 4331 05

9 R 2 Bis isoproproxycarbonyl oxy methoxy phosphinyl

methoxyl propyl adenine fumarate 1:1

ICN 13 CAS 202138 50 9

Lot Number : 13AB123A1 Drum Number 1 of 3

Gross Weight: 1,123kg Manufacture Date:

Tare Weight: 1,123kg Retest Date:

Net Weight: 1,123kg Customer P.O. Number P 03491

Storage 2 to 8 C

Caution: For manufacturing , processing, or repacking.

Caution: Rx only.


This test is shorter than 30
This test is shorter than 30
This test is shorter than 30
This test is shorter than 30
NOTIFY: This test is shorter than 30
This test is shorter than 30
This test is shorter than 30
This test is shorter than 30
WARNING STATEMENT
Tenofovir disoproxil fumarate
Emergency Overview
Material contained in bottles or cartons should not result in exposure or present a hazard.
However, contact with the powder may cause skin and or severe eye irritation. Avoid direct
contact with the substance. Wear gloves and promptly remove material on skin, eyes or clothing
by rinsing thoroughly with water.
MANUFACTURED FOR: Gilead Sciences,Ltd.
COUNTRY OF ORIGIN : Bahamas Rev 3 July 09 09

Tenofovir
(click image for full-size original)

TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate powder
Product Information
Product Type BULK INGREDIENT Item Code (Source) NDC:68668-351
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR) TENOFOVIR DISOPROXIL FUMARATE 1 kg in 1 kg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68668-351-01 1123 kg in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021356 10/01/2009
Labeler — PharmaChem Technologies (Grand Bahama) Ltd. (875064495)
Registrant — PharmaChem Technologies (Grand Bahama) Ltd. (875064495)
Establishment
Name Address ID/FEI Operations
PharmaChem Technologies (Grand Bahama) Ltd. 875064495 manufacture

Revised: 09/2009 PharmaChem Technologies (Grand Bahama) Ltd.