STRONTIUM CHLORIDE Sr-89 (Page 3 of 3)

HOW SUPPLIED/STORAGE AND HANDLING

STRONTIUM CHLORIDE Sr-89 INJECTION, USP is supplied in a 5 mL vial containing 148 MBq, 4 mCi. The vial is shipped in a transportation shield-container with a package insert, and two therapeutic agent-warning labels.

The vial and its contents should be stored inside its transportation container at room temperature (15-25°C, 59-77°F).

The calibration date and expiration date are quoted on the vial label. Do not use after the expiration date. Stability studies have shown no change in any of the product characteristics monitored during routine product quality control over the period from manufacture to expiration.

This radiopharmaceutical is licensed by the Texas Department of Health, or under equivalent licesnses of the U.S. Nuclear Regulatory Comminssion or an agreement state.

NDC72928-089-01

PRODUCT INFORMATION ISSUED: January 20, 2020

Manufactured for:
Q BioMed, Inc.
366 Madison Ave, Third Floor
New York, NY 10017

Manufactured by:
Isotherapeutics Group LLC
1004 S. Velasco St.
Angleton, Texas (TX) 77515

Printed in U.S.A.
L-089-11I
Product Code: P089-0

Drug Product Label

Vial Label

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(click image for full-size original)

Outer Container Label

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(click image for full-size original)

STRONTIUM CHLORIDE SR-89
strontium chloride sr-89 injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72928-089
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STRONTIUM CHLORIDE SR-89 (STRONTIUM CATION SR-89) STRONTIUM CATION SR-89 1 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72928-089-01 5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075941 01/06/2003
Labeler — Q BioMed Inc (055083004)
Registrant — Q BioMed Inc (055083004)
Establishment
Name Address ID/FEI Operations
IsoTherapeutics Group LLC 621139976 MANUFACTURE (72928-089)
Establishment
Name Address ID/FEI Operations
Narodowe Centrum Badan Jadrowych (dba Polatom) 422187116 api manufacture (72928-089)

Revised: 10/2022 Q BioMed Inc

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